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The purpose of this study is to help find out more about how the Primary Obesity Surgery Endoluminal (POSE) procedure makes patients feel less hungry and fuller faster, leading to weight loss. In this study, USGI Medical wants to see if stomach emptying and gastro-intestinal hormone levels change after a POSE procedure with an increased (as compared to typical) number of anchors placed.
This study will use the USGI Medical Incisionless Operating Platform (IOP) to determine the affects of placing more Suture Anchors per patient (as compared to the current practice) in Primary Obesity Surgery Endoluminal(POSE). USGI wants to see if placing more anchors (particularly in the distal body/antrum region) significantly impacts primary weight loss, satiety, and metabolic outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultimate Anchor | Experimental | Use of the g-Cath Suture Anchor Delivery Catheter and accessories in placing the ultimate number of anchors for weight loss. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| g-Cath Suture Anchor Delivery Catheter | Device | Evaluate changes in emptying, hormones, satiety and weight loss with use of the g-Cath Suture Anchor Delivery Catheter in maximizing g-Cath Suture Anchor placement to as high as 25 anchors. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Weight loss will be monitored and recorded on a monthly basis for up to 18 months post POSE with the proportion of subjects achieving ≥25% excess weight loss (EWL) at 12 months (Met Life criteria)being the primary efficacy endpoint | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying | This test consists of determining if there is a Clinically significant change in the duration of a radioactive marker (which is non-absorbable, and free of any food components) in a stomach pre and post POSE. In order to carry out this test, a piece of food is marked with a radioactive isotope and, by using an abdominal gamma camera; detections of radioactivity are made in the stomach during the postprandial period. |
| Measure | Description | Time Frame |
|---|---|---|
| Satiety | This test consists of determining if there is a Clinically significant change in Satiety pre and post POSE. 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. |
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 Teknon | Barcelona | 08022 | Spain |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 31, 2017 | |
| Reset | Jun 14, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 31, 2017 | Jun 14, 2017 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Immediately Pre-procedure, & 2 & 6 months post procedure |
| Immediately Pre-procedure, & 2 & 6 months post procedure |
| Peptide Measurements | This test consists of determining if there is a Clinically significant change in peptides pre and post procedure.
| Immediately Pre-procedure & 2 Months post procedure |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |