Gastric Tissue Stapler Comparison Study

NCT04086433 | Completed Results FDA Device

• 1 other identifier: CP-2018-01
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Pressure Evaluation

  Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.

  immediately post operative

• Staple Malformation

  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.

  through study completion, anticipate within 2 months

Study Arms (2)

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

Device: gastric tissue resection

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

Device: gastric tissue resection

Interventions

gastric tissue resection DEVICE

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

Arm A - Echelon Stapler; Arm B - Titan Stapler

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects undergoing Laparoscopic Sleeve Gastrectomy

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Standard Bariatrics: lead

Study Sites (1)

University at Buffalo

Buffalo, New York, 14203, United States

Location

Results Point of Contact

• Title: Alison Sathe
• Organization: Regulatory Mark

alison@regulatorymark.com

5133047971

Study Officials

• Aaron B Hoffman, MD, FACS

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: September 11, 2019
• Study Start: July 15, 2019
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: June 25, 2020
• Results First Posted: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)