Status:
ACTIVE_NOT_RECRUITING
A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
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 the clinical efficacy of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and...
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 the proposed follow-up visits.
- Patient has a contra-indication for laparoscopic bariatric surgery.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04808206
Start Date
June 1 2022
End Date
December 31 2025
Last Update
April 1 2025
Active Locations (3)
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1
Ziekenhuis Oost-Limburg, campus St.-Jan
Genk, Belgium
2
Hôpital de Nivelles, groupe Jolimont
Haine-Saint-Paul, Belgium
3
Ziekenhuis Maas en Kempen
Maaseik, Belgium