Status:
ACTIVE_NOT_RECRUITING
A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery
Lead Sponsor:
Duomed
Conditions:
Obesity
Roux-en-Y Gastric Bypass
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04422236
Start Date
September 28 2020
End Date
May 31 2025
Last Update
April 1 2025
Active Locations (1)
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1
AZ Delta vzw
Roeselare, Belgium