Endomina Controlled Study

Study Overview
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Brief Summary
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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 of all Adverse Device Effects (ADEs). A secondary endpoint is to compare a delayed treatment control group (diet alone; crossover at 6 months) with a treatment group (EVG plus diet). Other secondary endpoints include improvements in other obesity measures.

Detailed Description
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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 deviation and duodenal switch) or a combination of both (RYGBP). This latter technique is the most common and most effective surgical procedure performed worldwide and has been processed to be an effective treatment of morbid obesity and its complications, achieving excess weight loss of 65 to 80 %; 1-2 years after surgery. Vertical gastric plication is a novel surgical approach for reducing the stomach capacity. Anterior surface plication and greater curvature plication are variations of vertical gastric plication that reduce the gastric capacity through infolding of the anterior surface or greater curvature of the stomach, respectively. These approaches have been tested, with positive results. A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers the potential for additional benefit to the patient, because the procedures continue to become more and more minimally invasive. 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 their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with surgery and might become part of the armamentarium of obesity management. Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is a CE marked device that may be attached to an endoscope inside the body and allows remote actuation of the device during a peroral intervention. It offers the possibilities of making transoral full thickness tissue apposition and may allow performing, via a transoral route, large plications with tight serosa to serosa apposition. After a first trial on pigs (safety), a second trial on human patients was performed. This trial included 11 patients treated with the same technique. There were no complications and the short term results were encouraging with 41% EWL at 6 month. A multicentric trial NCT02582229 entitled:  A Prospective Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction.  is ongoing and inclusion of patients ended in December 2016 with a total of 51 patients included in 3 European centers. Early results of the trial had showed that dietician follow-up is an important part of the success. During that time implementation of the procedure had been done. The aim of this trial is to compare a control group (diet alone) with a treatment group (Endomina procedure plus diet).

Official Title
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A Controlled Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) as an Aid for Endoscopic Gastric Reduction

Conditions
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Obesity

Intervention / Treatment
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* Device: Endomina
* Behavioral: Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Group A: treatment J0 + Diet 1 year Group B: Diet 6 months - Treatment - Diet 1 year
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Endoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year | Device: Endomina<br>* Endoscopic sleeve reduction<br>|
| Active Comparator: Controled group<br>Diet for 6 months then Endoscopic sleeve gastroplasty (Endomina) with multidisciplinary follow-up for 1 year | Device: Endomina<br>* Endoscopic sleeve reduction<br>Behavioral: Diet<br>* Multidisciplinary follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all Adverse Device Effects | Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants. | one year from procedure | 
| Weight loss | total weight loss and excess weight loss | one year from procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss at 6 months | comparison between diet and treatment group at 6 months | at 6 months after the procedure (treatment group) | 
| More than 15% weight loss | Proportion of patients in the Endomina Group with a loss of weight of more than 15% | one year from procedure | 
| Quality of life | SF36 | one year from procedure | 
| TBWL | Mean % total body weight loss (%TBWL) | one year from procedure | 
| Weight and height | To calculate the body mass index (BMI) | one year from procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, endoscopy, endoscopic sleeve gastroplasty