A Prospective Study to Evaluate the Suture Pattern With the Endomina Suturing Device for Endoscopic Sutured Gastroplasty (ESG).

Study Overview
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Brief Summary
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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 (1). Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is CE mark device that may be attached to an endoscope inside the body and allows remote manipulation of the arms of the device during a peroral intervention. It offers the possibilities of making transoral surgical full thickness sutures and may allow performing endoscopic therapeutic interventions, via a transoral route. A first trial including 11 patients assessed feasibility and safety of the technique (2). There were no complications and the short-term results were encouraging. Then a multicentric efficacy study was conducted, including 51 patients (3). The results where EWL of 31% at one year and TBWL of 9% without complications. Finally a randomized controlled study was done including 73 patients in a 2/1 randomized fashion with a crossover at 6 months. Treated group was with the endomina device and controlled group was diet only. The follow-up was the same in each group. Primary endpoint was to reach the ASGE guideline difference between a control group and a treatment group of minimum 15% (4). Technique and suture pattern have evolved since the first study. The aim of this prospective evaluation is to compare different suture patterns and their mechanism of action.

Official Title
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A Prospective Study to Evaluate the Suture Pattern With the Endomina Suturing Device for Endoscopic Sutured Gastroplasty (ESG).

Conditions
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Obesity

Intervention / Treatment
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* Device: Endomina


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Volume reduction<br>Intragastric sutures are done to reduce the volume of the stomach | Device: Endomina<br>* The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of transmural anterior-posterior sutures in the stomach in order to achieve a gastric remodelling. Patient will be kept overnight after the procedure.<br>|
| Active Comparator: Gastric emptying reduction<br>Intragastric sutures are done to slower the gastric emptying | Device: Endomina<br>* The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of transmural anterior-posterior sutures in the stomach in order to achieve a gastric remodelling. Patient will be kept overnight after the procedure.<br>|
| Active Comparator: Increasing distension<br>Intragastric sutures are done to maximalize the gastric distension | Device: Endomina<br>* The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of transmural anterior-posterior sutures in the stomach in order to achieve a gastric remodelling. Patient will be kept overnight after the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | no difference in weight loss between groups | one year from procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying | Evaluation of the correlation between gastric emptying scintigraphy results and the suture pattern related to motility disruption | one year from procedure | 
| Satiety test assessed by the correlation between satiety test and the suture pattern related to volume reduction | Evaluation of the correlation between satiety test and the suture pattern related to volume reduction | one year from procedure | 
| sutures | Evaluation of the correlation between the number of remaining sutures (with gastric remodeling) and weight loss | one year from procedure | 
| Excess weight loss | Percentage of patients, total and per group, reaching ASGE guidelines of 25% Excess weight loss at 1-year | one year from procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopy, Mini invasive