A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery (SIRIUS)

Duomed

Status: Withdrawn

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

NCT04543526

DM-ZOL-01

Details and patient eligibility

About

The primary purpose of this observational registry is to evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during standard and robot-assisted laparoscopic Roux-en-Y Gastric Bypass (RYGB) surgery. Stapler performance during surgery as well as post-operative pain and the clinical efficacy of the procedures will be determined as secondary objectives.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient ≥ 18 years of age at study 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-morbidity.
• Patient has a BMI ≥ 40 kg/m2.
• Patient is eligible for standard laparoscopic or for robotic-assisted laparoscopic RYGB 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 study protocol or proposed follow-up visits.
• Patient has a contra-indication for standard laparoscopic or robot-assisted laparoscopic RYGB surgery.

Trial design

0 participants in 1 patient group

Obese patients

Description:

Obese patients eligible for standard laparoscopic or robot-assisted laparoscopic RYGB surgery.

Treatment:

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