Evaluation of a Powered Stapler System on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2015-11-01

Brief Summary

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This study will provide clinical data in an observational setting. Individuals undergoing LSG, and who meet study entry criteria, may be enrolled. LSG procedures will be performed according to institutional standard-of-care (SOC) using the study stapler. All study subjects will be followed for approximately 4 weeks for safety and outcomes.

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Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ECHELON FLEX™ Powered Plus Stapler

ECHELON FLEX™ Powered Plus Stapler using ENDOPATH ECHELON™ Reloads with Gripping Surface Technology (GST). The combination of stapler plus reload is referred to as the ECHELON FLEX™ GST System.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Scheduled for laparoscopic sleeve gastrectomy;
* Subject meets NIH weight loss surgical criteria;
* BMI ≤ 60 kg/m2;
* Willing to give consent and comply with study-related evaluations; and
* At least 18 years of age

Exclusion Criteria

* Previous bariatric procedures, including gastric banding;
* Prior gastric surgery;
* Scheduled concurrent surgical procedure (hiatal hernia repair, cholecystectomy allowed);
* Pregnancy;
* Known or suspected uncontrolled bleeding disorders;
* History of chronic steroid use;
* Patients who have undergone significant upper GI surgery leading to adhesion; formation, as determined by the Principal Investigator;
* Physical or psychological condition which would impair study participation;
* The patient is judged unsuitable for study participation by the Investigator for any other reason; or
* Unable or unwilling to attend follow-up visits and examinations.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No