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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volume reduction | Active Comparator | Intragastric sutures are done to reduce the volume of the stomach |
|
| Gastric emptying reduction | Active Comparator | Intragastric sutures are done to slower the gastric emptying |
|
| Increasing distension | Active Comparator | Intragastric sutures are done to maximalize the gastric distension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endomina | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | no difference in weight loss between groups | one year from procedure |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CUB Hopital erasme | Anderlecht | 1070 | Belgium | |||
| Gastroenterology Department Erasme Hospital |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
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 |
| Brussels |
| 1070 |
| Belgium |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |