Endostapler Sleeve Gastrectomy Study

Obesity Clinical Trial

Official title:

A Randomized Study Comparing Endostaplers in Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04617574
• Other study ID #: Endostapler02
• Status: Completed
• Start date: September 15, 2020
• Est. completion date: July 10, 2021

Study information

• Verified date: September 2021
• 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 measure AEON™ Endostapler performance for laparoscopic sleeve gastrectomy surgery versus the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic.

Description:

Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding from endoscopic images, evaluated by a blinded third-party. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG 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: Completed
• Enrollment: 60
• Est. completion date: July 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing planned laparoscopic sleeve gastrectomy

• 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 Partial Thromboplastin Time (PTT) >45sec, or Prothrombin Time (PT) >15sec, or International Normalized Ratio (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
• Endo GIA Reloads with Tri-Staple Technology
Surgery with Endo GIA Reloads with Tri-Staple Technology

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	Intraoperative Endoscopic Staple Line Bleeding Score	Intraoperative staple line bleeding score from endoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.	Within surgery, after the last stapler firing
Primary	Intraoperative Laparoscopic Staple Line Bleeding Score	Intraoperative staple line bleeding score from laparoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.	Within surgery, images captured 10 seconds after the last stapler firing
Secondary	Number of Participants With Postoperative Leakage Requiring Intervention	Number of participants with postoperative leakage requiring intervention	Within 30-day post-operative period
Secondary	Number of Participants With Intraoperative or Postoperative Blood Transfusion	Number of participants with intraoperative or postoperative blood transfusion	Within 72 hours of surgery start time
Secondary	Number of Participants With Reported Device-related Adverse Events	Number of participants with reported device-related adverse events	Within 30-day post-operative period
Secondary	Number of Participants With Product Malfunction	Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended.	Within surgery