Endostapler Sleeve Gastrectomy Study

Lexington Medical

Status

Completed

Conditions

Obesity

Treatments

Device: Endo GIA Reloads with Tri-Staple Technology

Device: AEON Endostapler

Study type

Observational

Funder types

Industry

Identifiers

NCT04617574

Endostapler02

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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