Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery

Duomed

Status: Completed

Conditions: Obesity; Roux-en-Y Gastric Bypass

Treatments: Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Study type: Observational

Funder types: Industry

Identifiers

NCT03968757

STAP-D

Details and patient eligibility

About

The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical used in laparoscopic RYGB 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: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age at study entry is at least 18 years.
2. Patient must sign and date the informed consent form prior to the index-procedure. If the patient is not able to give informed consent, a legally authorized representative must give informed consent on his/her behalf.
3. Patient has a BMI ≥ 35 kg/m2 with one of more related co-morbidities.
4. Patient has a BMI ≥ 40 kg/m2.

Exclusion criteria

1. Patient is pregnant.
2. History of bariatric surgery.
3. Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).

Trial design

150 participants in 1 patient group

Obese patients eligible for laparoscopic RYGB surgery.

Treatment:

Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)