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Gastric Tissue Stapler Comparison Study

NCT04086433 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2020-06-25

Study results available
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Summary

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.

Conditions

  • Gastric Resection

Interventions

DEVICE

gastric tissue resection

human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment

Sponsors & Collaborators

  • Standard Bariatrics

    lead INDUSTRY

Principal Investigators

  • Aaron B Hoffman, MD, FACS · University at Buffalo

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2019-10-30
Completion
2019-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04086433 on ClinicalTrials.gov