Stapler Post-market Observational Study

Duomed

Status: Completed

Conditions: Observational

Treatments: Device: Endoscopic Linear Cutter Stapler and reloads

Study type: Observational

Funder types: Industry

Identifiers

NCT02922205

ST-01

Details and patient eligibility

About

The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age at study entry is at least 18 years.
• Patient must sign and date the informed consent form prior to the index-procedure.
• Patient has a BMI ≥ 35 kg/m with one or more related co-morbidity.
• Patient has a BMI ≥ 40 kg/m.

Exclusion criteria

• Patient is pregnant.
• History of bariatric surgery.
• Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.

Trial design

100 participants in 1 patient group

RYGB surgery

Description:

Obese patients eligible for laparoscopic Roux-en-Y gastric bypass (RYGB) surgery.

Treatment:

Device: Endoscopic Linear Cutter Stapler and reloads