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Completed

NCT Number: NCT04617574

Endostapler Sleeve Gastrectomy Study

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Holyoke Medical Center

Holyoke, Massachusetts, 01040, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AEON Endostapler

Device

Surgery with AEON Endostapler

Endo GIA Reloads with Tri-Staple Technology

Device

Surgery with Endo GIA Reloads with Tri-Staple Technology

Primary outcomes

  1. Intraoperative Endoscopic Staple Line Bleeding Score

    Time frame: 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.

  2. Intraoperative Laparoscopic Staple Line Bleeding Score

    Time frame: 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 outcomes

  1. Number of Participants With Postoperative Leakage Requiring Intervention

    Time frame: Within 30-day post-operative period

    Number of participants with postoperative leakage requiring intervention

  2. Number of Participants With Intraoperative or Postoperative Blood Transfusion

    Time frame: Within 72 hours of surgery start time

    Number of participants with intraoperative or postoperative blood transfusion

  3. Number of Participants With Reported Device-related Adverse Events

    Time frame: Within 30-day post-operative period

    Number of participants with reported device-related adverse events

  4. Number of Participants With Product Malfunction

    Time frame: Within surgery

    Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended.

Sponsors and collaborators

Lead sponsor

Lexington Medical Inc.

Industry

Registry information

Official study title

A Randomized Study Comparing Endostaplers in Sleeve Gastrectomy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2020
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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