Trial Outcomes & Findings for Safety and Performance of ENTACT Septal Staple System for Septoplasty (NCT NCT04392583)
NCT ID: NCT04392583
Last Updated: 2022-06-15
Results Overview
At the 21-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: * Septum wall straight appearance (yes/no) * Complete coaptation of perichondrial flaps on septum wall (yes/no) * Absence of significant local tissue reaction at the staple site (yes/no) * Absence of hematoma swelling at the staple site (yes/no) * No need for re-intervention at the surgery site (yes/no) If all the answers to the questions above were "YES" then clinical success was inferred (if any answer was "NO" then repair failure was inferred).
COMPLETED
40 participants
21 days
2022-06-15
Participant Flow
The enrollment for this study was conducted between 22 October 2020 and 25 June 2021 across three investigative sites.
Participant milestones
| Measure |
Device: ENTACT Septal Staple
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
|
39
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Device: ENTACT Septal Staple
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
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|---|---|
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Overall Study
Participant declined follow-up and subsequently withdrawn
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1
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Baseline Characteristics
Safety and Performance of ENTACT Septal Staple System for Septoplasty
Baseline characteristics by cohort
| Measure |
Device: ENTACT Septal Staple
n=40 Participants
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
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|---|---|
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Age, Continuous
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44.4 years
STANDARD_DEVIATION 18.32 • n=99 Participants
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Sex: Female, Male
Female
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14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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36 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Asian Indian
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Chinese
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0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Japanese
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Korean
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Southeast Asian
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Singaporean
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Indonesian
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Thai
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Cambodian
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0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Laotian
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0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Malaysian
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0 Participants
n=99 Participants
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|
Race/Ethnicity, Customized
Race · Filipino
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Vietnamese
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Myanmarese
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Bruneian
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Timor Lestian
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0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Other Asian
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0 Participants
n=99 Participants
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|
Race/Ethnicity, Customized
Race · Black or African American
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1 Participants
n=99 Participants
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Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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|
Race/Ethnicity, Customized
Race · White
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37 Participants
n=99 Participants
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|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=99 Participants
|
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Region of Enrollment
United States
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40 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
At the 21-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed YES or NO: * Septum wall straight appearance (yes/no) * Complete coaptation of perichondrial flaps on septum wall (yes/no) * Absence of significant local tissue reaction at the staple site (yes/no) * Absence of hematoma swelling at the staple site (yes/no) * No need for re-intervention at the surgery site (yes/no) If all the answers to the questions above were "YES" then clinical success was inferred (if any answer was "NO" then repair failure was inferred).
Outcome measures
| Measure |
Device: ENTACT Septal Staple
n=38 Participants
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
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|---|---|
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Percentage of Participants With Clinical Success of the ENTACT Septal Staple System by Examining the Participant's Nasal Cavity at the 21 Day Follow-up Visit
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94.7 percentage of participants
Interval 82.0 to 99.0
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SECONDARY outcome
Timeframe: Day: 5, 21, and 42Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed "YES" or "NO": Septum wall straight appearance.
Outcome measures
| Measure |
Device: ENTACT Septal Staple
n=39 Participants
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
|
|---|---|
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Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 5 · Yes
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34 Participants
|
|
Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 5 · No
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3 Participants
|
|
Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 21 · Yes
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36 Participants
|
|
Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 21 · No
|
2 Participants
|
|
Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 42 · Yes
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38 Participants
|
|
Number of Participants With Septum Wall Straight Appearance at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 42 · No
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1 Participants
|
SECONDARY outcome
Timeframe: Day: 5, 21, and 42Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed "YES" or "NO": Complete coaptation of perichondrial flaps on septum wall.
Outcome measures
| Measure |
Device: ENTACT Septal Staple
n=39 Participants
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
|
|---|---|
|
Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 5 · Yes
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35 Participants
|
|
Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 5 · No
|
2 Participants
|
|
Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 21 · Yes
|
38 Participants
|
|
Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 21 · No
|
0 Participants
|
|
Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 42 · Yes
|
39 Participants
|
|
Number of Participants With Complete Coaptation of Perichondrial Flaps on Septum Wall at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 42 · No
|
0 Participants
|
SECONDARY outcome
Timeframe: Day: 5, 21, and 42Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed "YES" or "NO": Absence of significant local tissue reaction at the staple site.
Outcome measures
| Measure |
Device: ENTACT Septal Staple
n=39 Participants
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
|
|---|---|
|
Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 5 · Yes
|
35 Participants
|
|
Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 5 · No
|
2 Participants
|
|
Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 21 · Yes
|
38 Participants
|
|
Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 21 · No
|
0 Participants
|
|
Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 42 · Yes
|
39 Participants
|
|
Number of Participants With Absence of Significant Local Tissue Reaction at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 42 · No
|
0 Participants
|
SECONDARY outcome
Timeframe: Day: 5, 21, and 42Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed "YES" or "NO": Absence of hematoma swelling at the staple site.
Outcome measures
| Measure |
Device: ENTACT Septal Staple
n=39 Participants
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
|
|---|---|
|
Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 5 · Yes
|
37 Participants
|
|
Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 5 · No
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0 Participants
|
|
Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 21 · Yes
|
38 Participants
|
|
Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 21 · No
|
0 Participants
|
|
Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 42 · Yes
|
39 Participants
|
|
Number of Participants With Absence of Hematoma Swelling at the Staple Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 42 · No
|
0 Participants
|
SECONDARY outcome
Timeframe: Day: 5, 21, and 42Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
At the 5, 21, and 42-day follow-up visit, the clinician examined the participant's nasal cavity and confirmed "YES" or "NO": No need for re-intervention at the surgery site.
Outcome measures
| Measure |
Device: ENTACT Septal Staple
n=39 Participants
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
|
|---|---|
|
Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 5 · Yes
|
37 Participants
|
|
Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 5 · No
|
0 Participants
|
|
Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 21 · Yes
|
38 Participants
|
|
Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 21 · No
|
0 Participants
|
|
Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 42 · Yes
|
38 Participants
|
|
Number of Participants With No Need for Re-intervention at the Surgery Site at 5, 21, and 42-day Follow-up Visit (YES/NO)
Day 42 · No
|
1 Participants
|
SECONDARY outcome
Timeframe: Day: 0 (Screening), 5, 21 and 42Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified. Last Observation Carried Forward (LOCF) method was only used to carry forward post-baseline data.
The Nasal Obstruction Symptom Evaluation (NOSE) scale is a patient reported outcome (PRO). The NOSE Scale allows participants to quantify their symptoms based on the severity of their nasal obstruction/congestion. The NOSE score range was 0-100 were 0 represented no obstruction (i.e., better outcome) and 100 represented extreme obstruction (i.e., worse outcome).
Outcome measures
| Measure |
Device: ENTACT Septal Staple
n=39 Participants
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
|
|---|---|
|
Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits
Day 21
|
39.9 score on a scale
Standard Deviation 19.13
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Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits
Screening
|
69.2 score on a scale
Standard Deviation 20.28
|
|
Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits
Day 5
|
62.5 score on a scale
Standard Deviation 23.33
|
|
Nasal Obstructions Symptom Evaluation (NOSE) Score Collected at Pre-op and All Post-operative Visits
Day 42
|
33.2 score on a scale
Standard Deviation 20.56
|
SECONDARY outcome
Timeframe: Day: 0 (Screening), 5, 21 and 42Population: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified. Last Observation Carried Forward (LOCF) method was only used to carry forward post-baseline data.
The Visual Analog Scale (VAS) for pain is a continuous scale completed by the participant who is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Scores range from 0-100 where a score of 0 represented no pain and a score of 100 indicated the worst pain possible.
Outcome measures
| Measure |
Device: ENTACT Septal Staple
n=39 Participants
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
|
|---|---|
|
Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits
Screening
|
9.6 score on a scale
Standard Deviation 19.82
|
|
Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits
Day 5
|
13.9 score on a scale
Standard Deviation 20.92
|
|
Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits
Day 21
|
6.0 score on a scale
Standard Deviation 12.40
|
|
Visual Analog Scale (VAS) Pain Score Collected at Pre-Op and All Post-Operative Visits
Day 42
|
2.0 score on a scale
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: During procedure, up to 97 minutesPopulation: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
Intra-operative surgery duration overall and by each surgery procedure combination (Septoplasty with Turbinate Reduction and Sinus Surgery, Septoplasty with Turbinate Reduction, Septoplasty with Sinus Surgery and Turbinectomy, and Septoplasty Alone) were recorded as time in minutes between start of the procedure and when the drapes are removed from the patient.
Outcome measures
| Measure |
Device: ENTACT Septal Staple
n=39 Participants
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
|
|---|---|
|
Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations
Overall
|
43.7 minutes
Standard Deviation 27.88
|
|
Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations
Septoplasty with Turbinate Reduction and Sinus Surgery
|
64.9 minutes
Standard Deviation 23.23
|
|
Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations
Septoplasty with Turbinate Reduction
|
20.4 minutes
Standard Deviation 7.31
|
|
Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations
Septoplasty with Sinus Surgery and Turbinectomy
|
67.0 minutes
Standard Deviation 12.73
|
|
Total Operation Time for the Procedure Overall and by Surgery Procedure Combinations
Septoplasty alone
|
25.0 minutes
Standard Deviation 15.72
|
SECONDARY outcome
Timeframe: During procedure, up to 306 secondsPopulation: The Full Analysis Set (FAS) included participants enrolled in the study that had at least one post-baseline visit and were able to provide available data at the time frame specified.
Intra-operative time to deploy staples overall and by each surgery procedure combination (Septoplasty with Turbinate Reduction and Sinus Surgery, Septoplasty with Turbinate Reduction, Septoplasty with Sinus Surgery and Turbinectomy, and Septoplasty Alone) were recorded as time in seconds between start of closure to when the stapler was handed back to the scrub nurse.
Outcome measures
| Measure |
Device: ENTACT Septal Staple
n=39 Participants
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
|
|---|---|
|
Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations
Overall
|
57.6 seconds
Standard Deviation 54.81
|
|
Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations
Septoplasty with Turbinate Reduction and Sinus Surgery
|
82.2 seconds
Standard Deviation 65.86
|
|
Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations
Septoplasty with Turbinate Reduction
|
28.1 seconds
Standard Deviation 12.06
|
|
Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations
Septoplasty with Sinus Surgery and Turbinectomy
|
125.0 seconds
Standard Deviation 22.63
|
|
Operative Closure Time With ENTACT Septal Stapler Procedure Overall and by Surgery Procedure Combinations
Septoplasty alone
|
22.0 seconds
Standard Deviation 4.58
|
Adverse Events
Device: ENTACT Septal Staple
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Device: ENTACT Septal Staple
n=40 participants at risk
Septoplasty
ENTACT Septal Staple system: The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
|
|---|---|
|
Injury, poisoning and procedural complications
PURULENT DRAINAGE OVER LEFT ANTERIOR ETHMOID
|
2.5%
1/40 • Number of events 1 • Time of surgery (i.e. when device used) through end of the study (6 week post-operative follow-up).
The Safety population (SAF) was used to analyze adverse events and included all enrolled participants who received the study device.
|
|
General disorders
COVID-19
|
2.5%
1/40 • Number of events 1 • Time of surgery (i.e. when device used) through end of the study (6 week post-operative follow-up).
The Safety population (SAF) was used to analyze adverse events and included all enrolled participants who received the study device.
|
|
General disorders
COUGH
|
2.5%
1/40 • Number of events 1 • Time of surgery (i.e. when device used) through end of the study (6 week post-operative follow-up).
The Safety population (SAF) was used to analyze adverse events and included all enrolled participants who received the study device.
|
|
General disorders
FATIGUE
|
2.5%
1/40 • Number of events 1 • Time of surgery (i.e. when device used) through end of the study (6 week post-operative follow-up).
The Safety population (SAF) was used to analyze adverse events and included all enrolled participants who received the study device.
|
|
Injury, poisoning and procedural complications
RIGHT NASAL SCAR BAND
|
2.5%
1/40 • Number of events 1 • Time of surgery (i.e. when device used) through end of the study (6 week post-operative follow-up).
The Safety population (SAF) was used to analyze adverse events and included all enrolled participants who received the study device.
|
|
Injury, poisoning and procedural complications
EPISTAXIS
|
2.5%
1/40 • Number of events 1 • Time of surgery (i.e. when device used) through end of the study (6 week post-operative follow-up).
The Safety population (SAF) was used to analyze adverse events and included all enrolled participants who received the study device.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60