Endostapler Sleeve Gastrectomy Study

Completed

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT04617574

Run by

Lexington Medical Inc.

People needed

60

Starts

2020-09-15

Expected to finish

2021-07-10

Last updated by the study team

2021-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients undergoing planned laparoscopic sleeve gastrectomy
• Informed consent for study obtained and signed from each subject

You may not qualify if…

• 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

Where it is running

• Holyoke Medical Center — Holyoke, Massachusetts, United States

Full record on ClinicalTrials.gov

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