Gastric Tissue Stapler Comparison Study

Completed

• Conditions: Gastric Resection
• Interventions: Device: gastric tissue resection

• Registration Number: NCT04086433
• Lead Sponsor: Standard Bariatrics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-15
• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30
• Results First Submitted: 2020-05-21
• Results First Submitted QC: 2020-05-21
• Status Verified: 2020-06
• Results First Posted: 2020-06-05
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm A - Echelon Stapler	gastric tissue resection	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	gastric tissue resection	Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation

Primary Outcome Measures

Name	Time	Method
Staple Malformation	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.
Pressure Evaluation	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.

Trial Locations

Locations (1)

University at Buffalo; 🇺🇸 Buffalo, New York, United States