Gastric Tissue Stapler Comparison Study

Overview

This study is conducted to compare performance characteristics of staple lines resecting the stomach in excised human gastric tissue with existing Echelon Flex Powered Plus GST System (Ethicon, size: 60mm, "Echelon") stapler and the Titan SGS (Standard Bariatrics, "Titan").

The Study is a single center clinical trial, randomized (1:1, Arm A – Ethicon Echelon 60 application, Arm B – Standard Bariatrics Titan SGS application) which utilizes the excised stomach tissue from up to 75 adults undergoing laparoscopic sleeve gastrectomy (LSG). This study will be conducted in the USA.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2019

Interventions

  • Device: gastric tissue resection
    • human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment

Arms, Groups and Cohorts

  • Arm A – Echelon Stapler
    • Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, “Echelon”) and evaluated for burst pressure and staple malformation
  • Arm B – Titan Stapler
    • Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, “Titan”) and evaluated for burst pressure and staple malformation

Clinical Trial Outcome Measures

Primary Measures

  • Pressure Evaluation
    • Time Frame: immediately post operative
    • Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.
  • Staple Malformation
    • Time Frame: through study completion, anticipate within 2 months
    • Staple line specimen will be sent to an independent laboratory for imaging. Percentage of malformed staples in test staple line will be recorded by an independent assessor.

Participating in This Clinical Trial

Inclusion Criteria

1. Laparoscopic sleeve gastrectomy patients at study site, ages 18 to 80

Exclusion Criteria

1. Prior gastric surgery (lap band, Nissen fundoplication, G tube, greater curve plication, etc.)

2. Gastric lesion recognized during surgery (entire specimen would be sent to pathology)

3. Stomach damaged during extraction

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Investigator Details

  • Lead Sponsor
    • Standard Bariatrics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Aaron B Hoffman, MD, FACS, Principal Investigator, University at Buffalo

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