Endostapler Sleeve Gastrectomy Study

Completed

Interventions: Device: Endo GIA Reloads with Tri-Staple Technology
Device: AEON Endostapler

Brief 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.

Detailed 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 & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Endo GIA Reloads with Tri-Staple Technology	Endo GIA Reloads with Tri-Staple Technology	Stapling performed with Endo GIA Reloads with Tri-Staple Technology
AEON Endostapler	AEON Endostapler	Stapling performed with AEON Endostapler

Primary Outcome Measures

Name	Time	Method
Intraoperative Endoscopic Staple Line Bleeding Score	Within surgery, after the last stapler firing	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.
Intraoperative Laparoscopic Staple Line Bleeding Score	Within surgery, images captured 10 seconds after the last stapler firing	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Postoperative Leakage Requiring Intervention	Within 30-day post-operative period	Number of participants with postoperative leakage requiring intervention
Number of Participants With Intraoperative or Postoperative Blood Transfusion	Within 72 hours of surgery start time	Number of participants with intraoperative or postoperative blood transfusion
Number of Participants With Reported Device-related Adverse Events	Within 30-day post-operative period	Number of participants with reported device-related adverse events
Number of Participants With Product Malfunction	Within surgery	Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended.