Endostapler Gastric Bypass Study

Obesity Clinical Trial

Official title:

Safety and Efficacy of the AEON™ Endostapler in Laparoscopic Roux-en-Y Gastric Bypass Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04712526
• Other study ID #: Endostapler03
• Status: Withdrawn
• Start date: January 18, 2021
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Lexington Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• AEON Endostapler
Surgery with AEON Endostapler

Locations

Country	Name	City	State
United States	Holyoke Medical Center	Holyoke	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lexington Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of reported device-related adverse events		Within 30-day post-operative period
Secondary	Endoscopic staple line bleeding	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)	Within surgery
Secondary	Laparoscopic staple line bleeding	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)	Within surgery
Secondary	Incidence of intraoperative or postoperative blood transfusion		Within 72 hours of surgery start time
Secondary	Incidence of product malfunction		Within surgery