Endostapler Gastric Bypass Study

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-18

Study Completion Date

2023-12-31

Brief Summary

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The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.

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Detailed Description

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Stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. The study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic Roux-en-Y gastric bypass (GB). The GB procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care.

Conditions

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Obesity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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AEON Endostapler

Stapling performed with AEON Endostapler

AEON Endostapler

Intervention Type DEVICE

Surgery with AEON Endostapler

Interventions

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AEON Endostapler

Surgery with AEON Endostapler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing planned laparoscopic Roux-en-Y gastric bypass
* Informed consent for study obtained and signed from each subject

Exclusion Criteria

* Planned open surgical approach
* Use of staple line reinforcement material (buttress)
* Revision or other bariatric procedure
* Patients with a bleeding disorder: known coagulopathy, or Platelets \<100,000, or PTT \> 45sec, or PT\> 15sec, or INR\>1.5
* Patients with active HIV or Hepatitis B
* Patients under the age of 18 on the date of the surgery
* Patients who are pregnant
* Patients using tobacco products within the last 2 weeks prior to surgery date
* Patients using cortisone or related products within the last 2 weeks prior to surgery date

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes