Gastric Tissue Stapler Comparison Study

Gastric Resection Clinical Trial

Official title:

Gastric Tissue Stapler Comparison Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086433
• Other study ID #: CP-2018-01
• Status: Completed
• Start date: July 15, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: June 2020
• Source: Standard Bariatrics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Resection

Intervention

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

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Standard Bariatrics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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