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This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same diet and exercise plan. Subjects will be randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or the sham procedure followed by diet and exercise. After un-blinding at 12 months post-treatment, sham patients can choose to have the treatment procedure as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | The treatment of obese patients with the placement of g-Cath EZ suture anchors along with Diet and Exercise |
|
| Sham Group | Sham Comparator | The treatment of obese patients with the sham procedure along with Diet and Exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placement of g-Cath EZ suture anchors | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Body Weight Loss | Evaluate the effectiveness of the g-Cath EZâ„¢ Suture Anchor Delivery Catheter (USGI Medical, San Clemente, CA, USA) with diet and exercise as an early weight loss intervention for Class I obesity subjects with at least one non-severe obesity related co-morbid condition or Class II obesity subjects with or without a non-severe obesity related co-morbid condition compared to a sham procedure, diet and exercise group. | Enrollment to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life scores (IWQOL) | Assessment of changes | enrollment to 12 months |
| Comorbid status | Assessment of changes from baseline at 12 months in hypertension, diabetes, and hyperlipidemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Lavin, MD | Crescent City Surgical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Healthcare | Scottsdale | Arizona | 85258 | United States | ||
| DeWitt Daughtry Family Department of Surgery University of Miami Miller School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28000425 | Result | Sullivan S, Swain JM, Woodman G, Antonetti M, De La Cruz-Munoz N, Jonnalagadda SS, Ujiki M, Ikramuddin S, Ponce J, Ryou M, Reynoso J, Chhabra R, Sorenson GB, Clarkston WK, Edmundowicz SA, Eagon JC, Mullady DK, Leslie D, Lavin TE, Thompson CC. Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial. Obesity (Silver Spring). 2017 Feb;25(2):294-301. doi: 10.1002/oby.21702. Epub 2016 Dec 21. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 13, 2023 | |
| Reset | Jul 5, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 13, 2023 | Jul 5, 2023 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
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| Sham procedure | Procedure |
|
| Diet and Exercise | Behavioral | A structured diet and exercise plan |
|
| Enrollment to 12 months |
| Eating Behavior changes | assessment of changes from baseline at 12 months in eating behavior scores (TFEQ) and subjective changes in food capacity, hunger, and satiety in both study groups | Enrollment to 12 months |
| Miami |
| Florida |
| 33166 |
| United States |
| Hamilton Medical Center | Dalton | Georgia | 30722 | United States |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| Crescent City Surgical Centre | Covington | Louisiana | 70433 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02120 | United States |
| University of MN, Fairview Health Services | Minneapolis | Minnesota | 55455 | United States |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Lexington Medical Center | West Columbia | South Carolina | 29169 | United States |
| Baptist Memorial | Memphis | Tennessee | 38120 | United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |