Trial Outcomes & Findings for Sleeve Gastrectomy Outcomes With Different Stapling Devices (NCT NCT02731079)

NCT ID: NCT02731079

Last Updated: 2026-01-12

Results Overview

Time to create sleeve.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 62 participants
• Primary outcome timeframe: Time from first staple firing to last staple firing, for up to 5 hours
• Results posted on: 2026-01-12

Participant Flow

Participants in the US scheduled to have a sleeve gastrectomy.

Participant milestones

Measure	Ethicon Group that will have sleeve gastrectomy performed using the Ethicon Echilon powered stapler with absorbable polymer membrane staple line reinforcement. Ethicon Echilon: Surgery performed with Ethicon powered stapler	Covidien Group that will have sleeve gastrectomy performed using the Covidien iDrive powered stapler with absorbable polymer membrane staple line reinforcement. Covidien iDrive: Surgery performed with Covidien powered stapler
Overall Study STARTED	32	30
Overall Study COMPLETED	32	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sleeve Gastrectomy Outcomes With Different Stapling Devices

Baseline characteristics by cohort

Measure	Covidien n=30 Participants Group that will have sleeve gastrectomy performed using the Covidien iDrive powered stapler with absorbable polymer membrane staple line reinforcement. Covidien iDrive: Surgery performed with Covidien powered stapler	Ethicon n=32 Participants Group that will have sleeve gastrectomy performed using the Ethicon Echilon powered stapler with absorbable polymer membrane staple line reinforcement. Ethicon Echilon: Surgery performed with Ethicon powered stapler	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=210 Participants	32 Participants n=19 Participants	62 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	26 Participants n=210 Participants	28 Participants n=19 Participants	54 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=210 Participants	4 Participants n=19 Participants	8 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	4 Participants n=210 Participants	5 Participants n=19 Participants	9 Participants n=8 Participants
Race (NIH/OMB) White	15 Participants n=210 Participants	16 Participants n=19 Participants	31 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=210 Participants	11 Participants n=19 Participants	22 Participants n=8 Participants
Region of Enrollment United States	30 Participants n=210 Participants	32 Participants n=19 Participants	62 Participants n=8 Participants

PRIMARY outcome

Timeframe: Time from first staple firing to last staple firing, for up to 5 hours

Population: Data not collected due to study termination prior to participants' assessment at this time points.

Time to create sleeve.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Time from first staple firing to last staple firing, for up to 5 hours

Population: Data not collected due to study termination prior to participants' assessment at this time point.

Percent of staple firings with technical difficulties

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Time from first staple firing to last staple firing, for up to 5 hours

Population: Data not collected due to study termination prior to participants' assessment at this time point.

Time to load staple cartridges

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first staple firing to end of the case, for up to 5 hours

Population: Data not collected due to study termination prior to participants' assessment at this time point.

Will note any incidental bleeding along staple line and how many maneuvers were needed to control it. Measured as: 1) None, 2) Single therapy, 3) Multiple therapy (Any combination of hemostatic modalities)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-operative appointment to up to 1 year post-operative, for up to 1 year after sleeve creation

Population: Data not collected due to study termination prior to participants' assessment at this time point.

Weight loss in percent excess body weight loss at 3 weeks, 6 weeks, 3 months, 6 months, and up to 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Immediate post-operative period to conclusion of study, for up to 5 hours

Population: Data not collected due to study termination prior to participants' assessment at this time point.

Staple line leak rates

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Immediate post-operative period to conclusion of study, for up to 30 days after sleeve creation

Population: Data not collected due to study termination prior to participants' assessment at this time point.

Hospital readmissions or emergency room visits; Will note reason for readmission

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Immediate post-operative period to conclusion of study, for up to 1 year after sleeve creation

Population: Data not collected due to study termination prior to participants' assessment at this time point.

Will note intervention required and indication; reasons include, but are not limiting to, staple line leak, hematoma, abscess, prolonged tachycardia suspicious for intra-abdominal pathology

Outcome measures

Outcome data not reported

Adverse Events

Covidien

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ethicon

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Ahnfeldt

William Beaumont Army Medical Center

Phone: 915-742-4442

Email: eric.p.ahnfeldt.mil@health.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place