Endostapler Gastric Bypass Study

Withdrawn

• Conditions: Obesity

• Registration Number: NCT04712526
• Lead Sponsor: Lexington Medical Inc.

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 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.

Study Timeline

• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Study Start: 2021-01-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of reported device-related adverse events	Within 30-day post-operative period

Secondary Outcome Measures

Name	Time	Method
Endoscopic staple line bleeding	Within surgery	Incidence of intraoperative staple line bleeding from endoscopic images as measured by the provided bleeding severity scale - Bleeding Severity Scale for Endoscope Images (1: No bleeding, 5: Profuse Bleeding)
Laparoscopic staple line bleeding	Within surgery	Incidence of intraoperative staple line bleeding from laparoscopic images as measured by the provided bleeding severity scale - Bleeding Severity Scale for Laparoscope Images (1: No bleeding, 5: Profuse Bleeding)
Incidence of intraoperative or postoperative blood transfusion	Within 72 hours of surgery start time
Incidence of product malfunction	Within surgery

Trial Locations

Locations (1)

Holyoke Medical Center; 🇺🇸 Holyoke, Massachusetts, United States