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OpenTrials
Completed

NCT Number: NCT04086433

Gastric Tissue Stapler Comparison Study

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.

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Key information

Conditions

Gastric Resection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University at Buffalo

Buffalo, New York, 14203, United States

Who can participate

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

Inclusion criteria

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

Exclusion criteria

  • Prior gastric surgery (lap band, Nissen fundoplication, G tube, greater curve plication, etc.)
  • Gastric lesion recognized during surgery (entire specimen would be sent to pathology)
  • Stomach damaged during extraction

Treatment and study plan

gastric tissue resection

Device

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Standard Bariatrics

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2019
Registry last updated
Jun 25, 2020

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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