Status:
COMPLETED
A Prospective Study to Evaluate the Suture Pattern With the Endomina Suturing Device for Endoscopic Sutured Gastroplasty (ESG).
Lead Sponsor:
Erasme University Hospital
Conditions:
Obesity
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
Advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. Although these procedures may not be as effective as t...
Eligibility Criteria
Inclusion
- Age between 18-64 years;
- BMI between 30 to 40 kg/m²
- Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, gastric emptying scintigraphy, satiety test, as well as laboratory investigations.
- Must be able to understand and be willing to provide written informed consent.
- Must have completed the multidisciplinary workup
Exclusion
- Achalasia and any other esophageal motility disorders
- Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity.
- Hypertension: uncontrolled hypertension during last 3 month
- Severe renal, hepatic, pulmonary disease or cancer;
- GI stenosis or obstruction
- Pregnancy or breastfeeding or willing to become pregnant within study duration
- History of gastric surgery (any type)
- Impending gastric surgery 60 days post intervention
- History of weight changes (±5% TBWL) within the previous 6 months
- Placement/removal of an intragastric balloon in less than 6 months
- Currently participating in other study
- HP positive
Key Trial Info
Start Date :
April 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2020
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03843801
Start Date
April 2 2019
End Date
November 26 2020
Last Update
March 2 2021
Active Locations (2)
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1
CUB Hopital erasme
Anderlecht, Belgium, 1070
2
Gastroenterology Department Erasme Hospital
Brussels, Belgium, 1070