Status:
COMPLETED
Endomina Controlled Study
Lead Sponsor:
Erasme University Hospital
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The aim of this trial is to evaluate the efficacy of an endoluminal vertical gastroplasty (EVG) using an endoluminal-suturing device. Safety will also be characterized, in particular by the incidence ...
Detailed Description
Surgery is currently the only effective treatment for morbid obesity and can be divided into restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary pancreatic deviat...
Eligibility Criteria
Inclusion
- Age between 18-65 years;
- Class I or class II obesity (i.e. 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, as well as laboratory investigations;
- Must be able to understand and be willing to provide written informed consent;
- Must live within 75 km of the treatment site;
- Had followed the bariatric multidisciplinary workup (blood analyses, dietician, psychologist and doctor appointments).
Exclusion
- Achalasia and any other esophageal motility disorders;
- Severe esophagitis;
- Gastro-duodenal ulcer;
- 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 months;
- Diabetes: uncontrolled diabetes (on insulin therapy or oral therapy with Hba1c \> 10%);
- TBWL \>5% over the last 6 months;
- Severe renal, hepatic, pulmonary disease or cancer;
- GI stenosis or obstruction;
- Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
- Previous bariatric surgery, balloon or other endoscopic obesity-related therapy;
- Anticoagulant therapy;
- Impending gastric surgery 60 days post intervention;
- Currently participating in other study
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2020
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03255005
Start Date
September 5 2017
End Date
March 26 2020
Last Update
May 20 2020
Active Locations (2)
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1
Gastroenterology Department Erasme Hospital
Brussels, Belgium, 1070
2
APHM Hopital Marseille Nord Hepato-Gastroentérologie et Oncologie Digestive
Marseille, France, 13915