Endostapler Gastric Bypass Study

Lexington Medical

Status

Withdrawn

Conditions

Obesity

Treatments

Device: AEON Endostapler

Study type

Observational

Funder types

Industry

Identifiers

NCT04712526

Endostapler03

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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