Trial Outcomes & Findings for The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study (NCT NCT03255174)
NCT ID: NCT03255174
Last Updated: 2026-04-08
Results Overview
Hemostasis was defined as no detectable bleeding at the TBS. Absolute time to hemostasis was defined as the absolute time elapsed from TBS identification to the last moment in time at which detectable bleeding at the TBS was observed. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
35 participants
Primary outcome timeframe
During surgical procedure on Day 0 (from TBS identification to the last moment in time at which detectable bleeding at TBS observed)
Results posted on
2026-04-08
Participant Flow
Participant milestones
| Measure |
EVARREST Fibrin Sealant Patch
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Overall Study
STARTED
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35
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Overall Study
Full Analysis Set
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31
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Overall Study
COMPLETED
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35
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
Baseline characteristics by cohort
| Measure |
EVARREST Fibrin Sealant Patch
n=35 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Age, Categorical
<=18 years
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35 Participants
n=527 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=527 Participants
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Age, Categorical
>=65 years
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0 Participants
n=527 Participants
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Age, Continuous
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4.59 Years
STANDARD_DEVIATION 4.341 • n=527 Participants
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Sex: Female, Male
Female
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15 Participants
n=527 Participants
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Sex: Female, Male
Male
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20 Participants
n=527 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=527 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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33 Participants
n=527 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=527 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=527 Participants
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|
Race (NIH/OMB)
Asian
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3 Participants
n=527 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=527 Participants
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Race (NIH/OMB)
Black or African American
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9 Participants
n=527 Participants
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Race (NIH/OMB)
White
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20 Participants
n=527 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=527 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=527 Participants
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PRIMARY outcome
Timeframe: During surgical procedure on Day 0 (from TBS identification to the last moment in time at which detectable bleeding at TBS observed)Population: Full analysis set (FAS) consisted of all enrolled and eligible participants for whom TBS was identified.
Hemostasis was defined as no detectable bleeding at the TBS. Absolute time to hemostasis was defined as the absolute time elapsed from TBS identification to the last moment in time at which detectable bleeding at the TBS was observed. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=31 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Absolute Time to Hemostasis
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4.00 Minutes
Interval 4.0 to 4.0
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SECONDARY outcome
Timeframe: 4 minutes after TBS identification (during surgical procedure on Day 0)Population: FAS consisted of all enrolled and eligible participants for whom TBS was identified.
Percentage of participants who achieved hemostatic success at 4 minutes was reported. A participant was considered hemostatic success at 4 minutes if the TBS was hemostatic at 4 minutes, and there was no re-bleeding that required treatment (other than observation only) at the TBS from 4 minutes following the first TBS identification through final fascial closure. Hemostasis was assessed at 4 minutes from TBS identification by carefully releasing manual compression and removing the surgical sponge (if used). TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=31 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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Percentage of Participants Who Achieved Hemostatic Success at 4 Minutes
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77.4 Percentage of participants
Interval 58.9 to 90.41
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SECONDARY outcome
Timeframe: 10 minutes after TBS identification (during surgical procedure on Day 0)Population: FAS consisted of all enrolled and eligible participants for whom TBS was identified.
Percentage of participants who achieved hemostatic success at 10 minutes was reported. A participant was considered hemostatic success at 10 minutes if the TBS was hemostatic at 10 minutes, and there was no re-bleeding that required treatment (other than observation only) at the TBS from 10 minutes following the first TBS identification through final fascial closure. Hemostasis was assessed at 10 minutes from TBS identification and at initiation of final fascial closure. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=31 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Percentage of Participants Who Achieved Hemostatic Success at 10 Minutes
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93.5 Percentage of participants
Interval 78.58 to 99.21
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SECONDARY outcome
Timeframe: During surgical procedure on Day 0 (from TBS identification to final fascial closure)Population: FAS consisted of all enrolled and eligible participants for whom TBS was identified.
Percentage of participants with no re-bleeding at the TBS was reported. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=31 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Percentage of Participants With No Re-bleeding at the TBS
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96.8 Percentage of participants
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SECONDARY outcome
Timeframe: From the day of surgical procedure (Day 0) up to 44-days post-surgeryPopulation: Safety analysis set included all participants who received treatment.
Percentage of participants with adverse events that were potentially related to bleeding at the TBS was reported. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. An adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, without judgment about causality.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=35 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Percentage of Participants With Adverse Events That Were Potentially Related to Bleeding at the TBS
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5.7 Percentage of participants
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SECONDARY outcome
Timeframe: From the day of surgical procedure (Day 0) up to 44-days post-surgeryPopulation: Safety analysis set included all participants who received treatment.
Percentage of participants with adverse events that were potentially related to thrombotic events at the TBS was reported. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression. An adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, without judgment about causality.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=35 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Percentage of Participants With Adverse Events That Were Potentially Related to Thrombotic Events
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0 Percentage of participants
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SECONDARY outcome
Timeframe: From the day of surgical procedure (Day 0) up to 44-days post-surgeryPopulation: Safety analysis set included all participants who received treatment.
Percentage of participants with re-treatment at the TBS was reported. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=35 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Percentage of Participants With Re-treatment at the TBS
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25.7 Percentage of participants
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SECONDARY outcome
Timeframe: From the day of surgical procedure (Day 0) up to 44-days post-surgeryPopulation: Safety analysis set included all participants who received treatment.
Percentage of participants with adverse events (including serious and non-serious) were reported. An adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, without judgment about causality. Data is reported for participants with at least one AE. Participants having more than one AE are counted only once in this outcome measure.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=35 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Percentage of Participants With Adverse Events
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68.6 Percentage of participants
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SECONDARY outcome
Timeframe: From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0)Population: Safety analysis set included all participants who received treatment. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure.
Change from baseline in laboratory parameter (hemoglobin) was reported.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=32 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Change From Baseline in Laboratory Parameter: Hemoglobin
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-5.59 Grams per liter (g/L)
Standard Deviation 16.353
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SECONDARY outcome
Timeframe: From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0)Population: Safety analysis set included all participants who received treatment. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure.
Change from baseline in laboratory parameter (hematocrit; expressed as liters of cells per liter of blood) was reported.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=25 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Change From Baseline in Laboratory Parameter: Hematocrit
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-0.02 Liters per liter (L/L)
Standard Deviation 0.048
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SECONDARY outcome
Timeframe: From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0)Population: Safety analysis set included all participants who received treatment. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure.
Change from baseline in laboratory parameter (platelets) was reported.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=31 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Change From Baseline in Laboratory Parameter: Platelets
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-18.87 10^9 cells per liter
Standard Deviation 130.724
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SECONDARY outcome
Timeframe: During surgical procedure on Day 0Population: Safety analysis set included all participants who received treatment. Here, 'N' (overall number of participants analyzed) signifies the number of participants evaluable for this outcome measure.
Estimated intraoperative blood loss was reported.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=33 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Estimated Intraoperative Blood Loss
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81.9 Milliliters (mL)
Standard Deviation 112.00
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SECONDARY outcome
Timeframe: From the day of surgical procedure (Day 0) up to 44-days post-surgeryPopulation: Safety analysis set included all participants who received treatment.
Number of participants with blood products transfusion was reported.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=35 Participants
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Number of Participants With Blood Products Transfusion
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11 Participants
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Adverse Events
EVARREST Fibrin Sealant Patch
Serious events: 9 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EVARREST Fibrin Sealant Patch
n=35 participants at risk
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Blood and lymphatic system disorders
Febrile neutropenia
|
8.6%
3/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
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|
General disorders
Pyrexia
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Infections and infestations
Catheter site infection
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2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Infections and infestations
Lower respiratory tract infection
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2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Nervous system disorders
Syncope
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Surgical and medical procedures
Central venous catheterisation
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
Other adverse events
| Measure |
EVARREST Fibrin Sealant Patch
n=35 participants at risk
Participants with mild or moderate soft tissue or parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery were treated with EVARREST Fibrin Sealant Patch (EVARREST). EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component used as an adjunct to hemostasis during surgery.
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|---|---|
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Cardiac disorders
Bradycardia
|
8.6%
3/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Cardiac disorders
Tachycardia
|
28.6%
10/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Eye disorders
Eye swelling
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.7%
2/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
5/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
10/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
3/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
2/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Gastrointestinal disorders
Toothache
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Gastrointestinal disorders
Vomiting
|
22.9%
8/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
General disorders
Feeling jittery
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
General disorders
Impaired healing
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
General disorders
Peripheral swelling
|
5.7%
2/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
General disorders
Pyrexia
|
22.9%
8/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Hepatobiliary disorders
Retrograde portal vein flow
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Infections and infestations
Enterobacter infection
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Infections and infestations
Influenza
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
5.7%
2/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
31.4%
11/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Blood lactic acid increased
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Blood magnesium abnormal
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Blood magnesium decreased
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Blood potassium abnormal
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Blood potassium decreased
|
11.4%
4/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Body temperature decreased
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Body temperature increased
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Coagulation time prolonged
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Culture urine positive
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Haemoglobin decreased
|
5.7%
2/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Hepatic enzyme increased
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Liver function test abnormal
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Oxygen saturation decreased
|
11.4%
4/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Platelet count decreased
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Prothrombin time abnormal
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Respiratory rate decreased
|
5.7%
2/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Staphylococcus test positive
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Investigations
Weight decreased
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Metabolism and nutrition disorders
Hypophagia
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Nervous system disorders
Dizziness
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Nervous system disorders
Dyskinesia
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Nervous system disorders
Somnolence
|
8.6%
3/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Nervous system disorders
Tremor
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Product Issues
Device leakage
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Psychiatric disorders
Agitation
|
5.7%
2/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Psychiatric disorders
Nervousness
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Renal and urinary disorders
Bladder dilatation
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Renal and urinary disorders
Polyuria
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
8.6%
3/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.6%
3/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.6%
3/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
5.7%
2/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.9%
1/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
2/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Vascular disorders
Hypertension
|
31.4%
11/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
|
Vascular disorders
Hypotension
|
11.4%
4/35 • From the day of surgical procedure (Day 0) up to 44-days post-surgery
Safety analysis set included all participants who received treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication or other public presentation of results from this study requires prior review by ETHICON. Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 30 working days prior to abstract or other relevant submission deadlines.
- Publication restrictions are in place
Restriction type: OTHER