A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery (STAP-Delta)

Duomed

Status: Active, not recruiting

Conditions: Obesity; Mini Gastric Bypass; Gastrectomy; Roux-en-Y Gastric Bypass

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04422236

DM-Delta-01

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 when used to create anastomoses during laparoscopic bariatric surgery. The goal of the study will be achieved by assessing the device performance and by reporting of peri- and postoperative complications in a prospectively maintained database.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient ≥ 18 years of age at registry entry.
• Patient and investigator signed and dated the informed consent form prior to the index-procedure.
• Patient has a BMI ≥ 35 kg/m2, with one or more related co-morbidities.
• Patient has a BMI ≥ 40 kg/m2.
• Patient is eligible for laparoscopic bariatric surgery.

Exclusion criteria

• Patient is unable / unwilling to provide informed consent.
• Patient has a history of bariatric surgery.
• Patient is unable to comply with the registry protocol or proposed follow-up visits.
• Patient has a contra-indication for laparoscopic bariatric surgery.

Trial design

200 participants in 1 patient group

Obese patients eligible for laparoscopic bariatric surgery

Treatment:

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