Status:
WITHDRAWN
Endostapler Gastric Bypass Study
Lead Sponsor:
Lexington Medical Inc.
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed 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 c...
Eligibility Criteria
Inclusion
- Patients undergoing planned laparoscopic Roux-en-Y gastric bypass
- Informed consent for study obtained and signed from each subject
Exclusion
- 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
Key Trial Info
Start Date :
January 18 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04712526
Start Date
January 18 2021
End Date
December 1 2023
Last Update
October 4 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Holyoke Medical Center
Holyoke, Massachusetts, United States, 01040