Trial Outcomes & Findings for Gastric Tissue Stapler Comparison Study (NCT NCT04086433)
NCT ID: NCT04086433
Last Updated: 2020-06-25
Results Overview
Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.
Recruitment status
COMPLETED
Target enrollment
36 participants
Primary outcome timeframe
immediately post operative
Results posted on
2020-06-25
Participant Flow
Participant milestones
| Measure |
Arm A - Echelon Stapler
Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation
gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
|
Arm B - Titan Stapler
Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation
gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm A - Echelon Stapler
n=17 Participants
Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation
gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
|
Arm B - Titan Stapler
n=18 Participants
Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation
gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=17 Participants
|
18 Participants
n=18 Participants
|
35 Participants
n=35 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=17 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
41 years
n=17 Participants
|
46 years
n=18 Participants
|
44 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=17 Participants
|
13 Participants
n=18 Participants
|
27 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=17 Participants
|
5 Participants
n=18 Participants
|
8 Participants
n=35 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
17 Participants
n=17 Participants
|
18 Participants
n=18 Participants
|
35 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: immediately post operativeBurst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.
Outcome measures
| Measure |
Arm A - Echelon Stapler
n=17 Participants
Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation
gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
|
Arm B - Titan Stapler
n=18 Participants
Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation
gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
|
|---|---|---|
|
Pressure Evaluation
|
126 mmHg
Interval 46.0 to 226.0
|
163 mmHg
Interval 82.0 to 259.0
|
PRIMARY outcome
Timeframe: through study completion, anticipate within 2 monthsStaple line specimen will be sent to an independent laboratory for imaging. Percentage of malformed staples in test staple line will be recorded by an independent assessor.
Outcome measures
Outcome data not reported
Adverse Events
Arm A - Echelon Stapler
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B - Titan Stapler
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A - Echelon Stapler
Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation
gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
|
Arm B - Titan Stapler
Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation
gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
|
|---|---|---|
|
Product Issues
Other
|
—
0/0 • Not applicable. Investigation performed on excised tissue.
Not applicable. Investigation performed on excised tissue.
|
—
0/0 • Not applicable. Investigation performed on excised tissue.
Not applicable. Investigation performed on excised tissue.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60