Gastric Tissue Stapler Comparison Study

Standard Bariatrics

Status: Completed

Conditions: Gastric Resection

Treatments: Device: gastric tissue resection

Study type: Observational

Funder types: Industry

Identifiers

NCT04086433

CP-2018-01

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

36 participants in 2 patient groups

Arm A - Echelon Stapler

Description:

Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation

Treatment:

Device: gastric tissue resection

Arm B - Titan Stapler

Description:

Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation

Treatment:

Device: gastric tissue resection