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

Active, not recruiting

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

• Registration Number: NCT04422236
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-09-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese patients eligible for laparoscopic bariatric 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) in laparoscopic bariatric surgery.	Follow-up 6: 24 months after the procedure	Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

Secondary Outcome Measures

Name	Time	Method
Device performance	At index procedure	Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).
Clinical efficacy	Follow-up 6: 24 months after the procedure	Comorbidity

Trial Locations

Locations (1)

AZ Delta vzw; 🇧🇪 Roeselare, Belgium