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

Completed

• Conditions: Roux-en-Y Gastric Bypass; Obesity
• Interventions: Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

• Registration Number: NCT03968757
• Lead Sponsor: Duomed

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-05-30
• Study Start: 2019-07-04
• Primary Completion: 2023-04-25
• Status Verified: 2023-06
• Study Completion: 2023-06-07
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese patients eligible for laparoscopic RYGB surgery.	easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)	at 24 months follow-up	Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of the laparoscopic RYGB surgery	at 24 months follow-up	Change of patient's weight
To evaluate the performance of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)	at index-procedure	Number of procedures with technical success, defined as laparoscopic Roux-en-Y gastric bypass formation as intended without technical difficulties and without conversion to open laparotomy.
To evaluate the performance of the easyEndoTM Universal Linear Cutting	at index-procedure	Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).

Trial Locations

Locations (1)

AZ Sint-Jan Brugge; 🇧🇪 Brugge, West Flanders, Belgium