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The purpose of this study is to evaluate the impact of minor variations in Incisionless Operating Platform (IOP)procedural techniques on gastric emptying, hormone levels, satiety, and weight loss in the treatment of primary obesity. It will confirm, in an open prospective study, the action mechanisms for the "POSE" endoscopic treatment technique for obesity, and it will help determine if they are maintained at least 6 months following the procedure. Durability of weight loss will be tracked through post-POSE visits up to 18 months following the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Horizontal row | Experimental | Use the IOP system from USGI to install suture anchors running from the distal body into the proximal antrum |
|
| Reduction in "ring" opening | Experimental | Use the IOP system from USGI to install suture anchors to reduce the "ring" opening to the antrum |
|
| Control Arm | Experimental | Use the IOP system from USGI to install suture anchors in the Current V shape in distal body |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Using The IOP system from USGI to place suture anchors | Device | Sutures are placed in the distal body in one of three randomized techniques: "A" = reduction in "ring" opening to antrum using plications "B" = continuous horizontal row, running from distal body into proximal antrum "C" = Control. Current V shape as Control |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Each patient's weight will be measured and recorded on a monthly basis out to 18 months post procedure | Monthly post procedure out to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting/Post-prandial Peptides |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric Emptying | This test consists of determining the duration of a radioactive marker in a stomach, which is non-absorbable, and free of any food components. | Pre-procedure & 2 & 6 months post procedure |
| Satiety Testing |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge C. Espinos, MD | Centro Medico Teknon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Medico | Barcelona | Catalonia | 08022 | Spain |
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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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| pre-procedure & 8 weeks post procedure |
The subjects ingest a nutritional drink (Ensure) at a constant rate of 30 mL per minute, constantly filling the glass with a perfusion pump (Gemini PC-2, IMED, San Diego, CA). (The subjects are not conscious of the volume being ingested.) The subjects are instructed to maintain consumption at the fill rate. Participants take note of their sensation of satiety with a graphical classification scale, which combines verbal descriptors on a scale of 0 to 5 (0 = no symptoms, 1 = first sensation of fullness [threshold]; 2 = light, 3 = moderate, 4 = severe, and 5 = maximum fullness or unbearable). The participants are told to stop taking the food product when a score of 5 is obtained. The maximum consumption of volume of the nutritional drink is recorded.
| Pre-procedure & 2 & 6 months post procedure |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |