Trial Outcomes & Findings for Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair (NCT NCT03495154)

NCT ID: NCT03495154

Last Updated: 2024-04-23

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

145 participants

Primary outcome timeframe

12 months post surgery

Results posted on

2024-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	Parietene DS Composite Mesh Patients treated with Parietene DS Composite Mesh Parietene DS Composite Mesh: All subjects enrolled will receive the Parietene DS Composite Mesh
Overall Study STARTED	145
Overall Study Full Analysis Set	125
Overall Study COMPLETED	104
Overall Study NOT COMPLETED	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Parietene DS Composite Mesh Patients treated with Parietene DS Composite Mesh Parietene DS Composite Mesh: All subjects enrolled will receive the Parietene DS Composite Mesh
Overall Study Screen Failures Pre-Operatively	4
Overall Study Withdrawn Prior to Surgery	10
Overall Study Screen Failures During Surgery	6
Overall Study Death	2
Overall Study Lost to Follow-up	16
Overall Study Withdrawal by Subject	2
Overall Study Unable to gather information from subject due to age and limited abilities	1

Baseline Characteristics

\[1\] Measure Analysis Population Description: Pregnancy test was only performed for female subjects of child bearing age and potential. Pregnancy tests for women are request at the time of screening and operation except for women who are post-menopausal for at least 2 years or surgically sterile. If screening was done the same day of operation (as permitted by CIP), only one pregnancy test is necessary.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parietene DS Composite Mesh n=125 Participants Patients treated with Parietene DS Composite Mesh Parietene DS Composite Mesh: All subjects enrolled will receive the Parietene DS Composite Mesh
Age, Continuous Overall	58.0 years STANDARD_DEVIATION 12.31 • n=125 Participants
Sex: Female, Male Female	51 Participants n=125 Participants
Sex: Female, Male Male	74 Participants n=125 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=125 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	121 Participants n=125 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=125 Participants
Region of Enrollment United States	125 participants n=125 Participants
Ethnicity Asian	1 Participants n=125 Participants
Ethnicity Black or African American	22 Participants n=125 Participants
Ethnicity White	98 Participants n=125 Participants
Ethnicity Latino/Hispanic	2 Participants n=125 Participants
Ethnicity Middle Eastern	1 Participants n=125 Participants
Ethnicity Patient Does Not Want to Disclose	1 Participants n=125 Participants
Height, cm	172.5 centimeters STANDARD_DEVIATION 11.15 • n=125 Participants
Weight, kg	98.4 kilograms STANDARD_DEVIATION 15.96 • n=125 Participants
BMI, kg/m^2	33.2 kg/m^2 STANDARD_DEVIATION 4.82 • n=125 Participants
Pregnancy Test Performed Pregnancy Test at Screening Visit · Pregnancy Test Administered: Yes	10 Participants n=51 Participants • \[1\] Measure Analysis Population Description: Pregnancy test was only performed for female subjects of child bearing age and potential. Pregnancy tests for women are request at the time of screening and operation except for women who are post-menopausal for at least 2 years or surgically sterile. If screening was done the same day of operation (as permitted by CIP), only one pregnancy test is necessary.
Pregnancy Test Performed Pregnancy Test at Screening Visit · Pregnancy Test Administered: No	41 Participants n=51 Participants • \[1\] Measure Analysis Population Description: Pregnancy test was only performed for female subjects of child bearing age and potential. Pregnancy tests for women are request at the time of screening and operation except for women who are post-menopausal for at least 2 years or surgically sterile. If screening was done the same day of operation (as permitted by CIP), only one pregnancy test is necessary.
Pregnancy Test Performed Pregnancy Test at Operative Visit · Pregnancy Test Administered: Yes	5 Participants n=27 Participants • \[1\] Measure Analysis Population Description: Pregnancy test was only performed for female subjects of child bearing age and potential. Pregnancy tests for women are request at the time of screening and operation except for women who are post-menopausal for at least 2 years or surgically sterile. If screening was done the same day of operation (as permitted by CIP), only one pregnancy test is necessary.
Pregnancy Test Performed Pregnancy Test at Operative Visit · Pregnancy Test Administered: No	22 Participants n=27 Participants • \[1\] Measure Analysis Population Description: Pregnancy test was only performed for female subjects of child bearing age and potential. Pregnancy tests for women are request at the time of screening and operation except for women who are post-menopausal for at least 2 years or surgically sterile. If screening was done the same day of operation (as permitted by CIP), only one pregnancy test is necessary.

PRIMARY outcome

Timeframe: 12 months post surgery

Population: Hernia recurrence rate at 12M changed from what was previously reported, 4 (3.5%) due to data imputed for hernia recurrence. It was assumed subjects who missed the 12M visit and had no recurrence at 24M also had no recurrence at 12M, as hernias cannot appear and then disappear over time without treatment. There were 5 subjects excluded from the primary endpoint analysis due to not completing the 12M/24M visits and therefore, unable to determine if a recurrence occurred in these subjects.

Outcome measures

Outcome measures
Measure	Parietene DS Composite Mesh n=120 Participants Patients treated with Parietene DS Composite Mesh Parietene DS Composite Mesh: All subjects enrolled will receive the Parietene DS Composite Mesh
Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair Subjects With Hernia Recurrence at 12-Months	4 Participants
Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair Subjects Without Hernia Recurrence at 12-Months	116 Participants

SECONDARY outcome

Timeframe: operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery

Outcome measures

Outcome measures
Measure	Parietene DS Composite Mesh n=125 Participants Patients treated with Parietene DS Composite Mesh Parietene DS Composite Mesh: All subjects enrolled will receive the Parietene DS Composite Mesh
Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair. Number of participants with incidence of ADEs Intra-Operatively	0 number of participants with ADEs
Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair. Number of participants with incidence of ADEs at Discharge	14 number of participants with ADEs
Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair. Number of participants with incidence of ADEs within 1 Month	31 number of participants with ADEs
Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair. Number of participants with incidence of ADEs within 3 Months	34 number of participants with ADEs
Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair. Number of participants with incidence of ADEs within 12 Months	40 number of participants with ADEs
Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair. Number of participants with incidence of ADEs within 24 Months	42 number of participants with ADEs

SECONDARY outcome

Timeframe: 1 month, 3 months, and 24 months post-surgery

Population: The overall number of participants analyzed may vary at different follow-up time points due to some assessments not being completed, which are required for inclusion in the analysis. At Baseline and Procedure there were 125 patients treated; each follow-up visit was missing some of those treated patients. Pre-specified full analysis set was inclusive of patients that missed follow-up. Subjects were not considered lost to follow-up until the 24M follow-up period was completed.

Outcome measures

Outcome measures
Measure	Parietene DS Composite Mesh n=125 Participants Patients treated with Parietene DS Composite Mesh Parietene DS Composite Mesh: All subjects enrolled will receive the Parietene DS Composite Mesh
Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair Participants with hernia recurrence within 1 month	0 Participants
Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair Participants with hernia recurrence within 3 months	0 Participants
Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair Participants with hernia recurrence within 24 months	4 Participants

Adverse Events

Parietene DS Composite Mesh

Serious events: 29 serious events

Other events: 20 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Parietene DS Composite Mesh n=125 participants at risk Patients treated with Parietene DS Composite Mesh Parietene DS Composite Mesh: All subjects enrolled will receive the Parietene DS Composite Mesh
Cardiac disorders Atrial Fibrillation	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Gastrointestinal disorders Abdominal Hernia	1.6% 2/125 • Number of events 2 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Gastrointestinal disorders Abdominal Pain	1.6% 2/125 • Number of events 2 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Gastrointestinal disorders Ileus Paralytic	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Gastrointestinal disorders Pancreatitis Acute	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Infections and infestations Abdominal Wall Abscess	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Infections and infestations Abscess	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Infections and infestations COVID-19 Pneumonia	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Infections and infestations Cellulitis	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Injury, poisoning and procedural complications Procedural Nausea	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Injury, poisoning and procedural complications Procedural Pain	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Investigations Hemoglobin Decreased	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Carcinoma Metastatic	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Neuroendocrine Tumour	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Renal and urinary disorders Urinary Retention	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Reproductive system and breast disorders Breast Necrosis	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.4% 3/125 • Number of events 3 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Surgical and medical procedures Pacemaker Generated Rhythm	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Vascular disorders Aortic Stenosis	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Cardiac disorders Cardiac Failure	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
General disorders Ileus	2.4% 3/125 • Number of events 3 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Gastrointestinal disorders Internal Hernia	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Gastrointestinal disorders Oesophageal Stenosis	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Infections and infestations Pneumonia	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Gastrointestinal disorders Umbilical Hernia	0.80% 1/125 • Number of events 1 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Injury, poisoning and procedural complications Postoperative Ileus	1.6% 2/125 • Number of events 2 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.

Other adverse events

Other adverse events
Measure	Parietene DS Composite Mesh n=125 participants at risk Patients treated with Parietene DS Composite Mesh Parietene DS Composite Mesh: All subjects enrolled will receive the Parietene DS Composite Mesh
Injury, poisoning and procedural complications Seroma	10.4% 13/125 • Number of events 13 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.
Gastrointestinal disorders Abdominal Pain	5.6% 7/125 • Number of events 7 • Starting at the time the participant is enrolled and receives the study device up to and including 24 months post-operative Adverse events (AE) is defined in the PPDS protocol as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. Serious adverse event (SAE) definition in PPDS protocol is consistent with definition defined by clinicaltrials.gov.

Additional Information

Alyssa Sutch, Senior Clinical Research Specialist

Medtronic

Phone: 612-214-9756

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place