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| Name | Class |
|---|---|
| Erbe USA Incorporated | OTHER |
| Erbe Elektromedizin GmbH | INDUSTRY |
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The purpose of this research is to evaluate the clinical safety, durability, and weight loss outcomes of the hybrid argon plasma coagulation + endoscopic sleeve gastroplasty (HAPC-ESG) procedure when compared to traditional endoscopic sleeve gastroplasty (ESG) alone. ESG was proven to be feasible in human subjects in 2013 and since then has become the most commonly performed endoscopic bariatric remodeling procedure. However, this procedure may be enhanced with the addition of the hybrid argon plasma coagulation (HAPC) technique, leading to enhanced weight loss, durability, and metabolic benefits. Argon plasma coagulation (APC) is a method of non-contact thermal hemostasis initially created to assist in inducing hemostasis utilizing a high-frequency current to the targeted area. This is a validation study of a pilot randomized control trial which will evaluate the safety, durability, and effects on weight loss of the combined HAPC-ESG approach when compared to traditional ESG alone.
Obesity is a chronic disease state driven by the imbalance of caloric intake and expenditure and mediated by multiple central and peripheral pathways that may serve as targets for therapeutic interventions. The endoscopic sleeve gastroplasty (ESG) is a per oral gastric remodeling technique that employs full-thickness suturing to imbricate the stomach along the greater curvature to achieve a restricted, sleeve-like configuration. Argon Plasma Coagulation (APC) is a method of non-contact thermal hemostasis which utilizes a high-frequency current applied to the target tissue through an argon plasma jet to induce hemostasis and a homogenous surface coagulation with a limited depth of penetration. APC is a widely used therapy in the luminal digestive tract to provide non-contact, targeted thermal injury for mucosal ablation and may therefore allow for a greater submucosal component of healing between tissue plications and, consequently, greater durability of the gastroplasty. Enhanced fibrosis along the site of endoscopic plications with the addition of APC could decrease the incidence of weight regain in patients undergoing ESG and capitalize on the metabolic benefits of gastric mucosal revitalization reported with APC alone. In this study, the investigators propose to evaluate the durability of endoscopic plications, weight loss outcomes, and improvements in obesity related co-morbidities for the combined hybrid argon plasma coagulation plus endoscopic sleeve gastroplasty (HAPC-ESG) procedure when compared to traditional ESG. Investigators hypothesize that HAPC-ESG will provide greater durability of the gastroplasty construct than traditional ESG. This is a single-center, randomized, single-blinded clinical trial evaluating the efficacy and safety of HAPC-ESG for weight loss and improvement in obesity-related co-morbidities compared to ESG alone. The study population includes adult patients who are seeking ESG at True You Weight Loss in Cary, NC with a BMI ≥ 30 and ≤40 kg/m² who have failed to achieve and maintain weight loss with a non-surgical management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty | Experimental | Hybrid APC will be utilized to first ablate the gastric mucosa along the greater curve of the stomach, followed immediately by endoscopic full-thickness tissue acquisition and plication using 2-0 Prolene synthetic sutures via the Apollo ESG platform. |
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| Endoscopic Sleeve Gastroplasty | Active Comparator | Endoscopic full-thickness tissue acquisition and plication using 2-0 Prolene synthetic sutures via the Apollo ESG platform. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Argon Plasma Coagulation | Procedure | Hybrid APC will be utilized to first ablate the gastric mucosa along the greater curve of the stomach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Durability assessed by blinded physician(s) with expertise in endoscopic sleeve gastroplasty (ESG) procedures graded according to a priori standardized criteria. | The primary outcomes are durability of plications and endoscopic sutures on repeat endoscopy at 6 months, in the two randomized arms. Durability of plications and endoscopic sutures will be assessed by blinded physician(s) with expertise in ESG who will assess sleeve-like anatomy (scale: None, Some, Typical), tissue bonding (scale: None, Some, Plenty), and tightness of sutures (scale: Loose, Somewhat tight, Tight) to measure durability. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| %TBWL | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis | 6 Month |
| %EWL | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher E McGowan, MD, MSCR | CEO/Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| True You Weight Loss | Cary | North Carolina | 27513 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32487284 | Background | Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. NCHS Data Brief. 2020 Feb;(360):1-8. | |
| 31851800 | Background | Ward ZJ, Bleich SN, Cradock AL, Barrett JL, Giles CM, Flax C, Long MW, Gortmaker SL. Projected U.S. State-Level Prevalence of Adult Obesity and Severe Obesity. N Engl J Med. 2019 Dec 19;381(25):2440-2450. doi: 10.1056/NEJMsa1909301. |
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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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1:1 allocation to experimental and control group using variable block randomization
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Participants and care providers will be blinded to the results of randomization. They will remain blinded until the end of the study, or if there is a medical or surgical safety concern.
| Endoscopic Sleeve Gastroplasty | Procedure | Endoscopic full-thickness tissue acquisition and plication using 2-0 Prolene synthetic sutures via the Apollo ESG platform. |
|
| 6 and 12 month |
| Blood Pressure | Systolic and diastolic blood pressure compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis | 6 month |
| HbA1c percentage | Percentage of red blood cells that have glucose-coated hemoglobin compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis | 6 Month |
| Change in quality of life measured by Questionnaire: Short Form Health Survey (SF-36) | Changes in Short Form Health Survey responses compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Minimum score of 38 and maximum score of 149. Quality of life outcome determined by changes in individual scores on each respective question. | 6 Month |
| Change in quality of life measured by Questionnaire: Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Changes in Impact of Weight on Quality of Life-Lite responses compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Minimum score of 31 and maximum score of 155 with a higher score reflective of poor self-assessed quality of life. | 6 Month |
| Change in depression measured by Questionnaire: Patient Health Questionnaire (PHQ-9) | Changes in Patient Health Questionnaire (PHQ-9) responses compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Minimum score of 0 and maximum score of 27 with lower scores reflective of no or mild depression, medium scores reflective of moderate depression, and high scores reflective of severe depression. | 6 Month |
| Change in eating behavior measured by Questionnaire: The Three-Factor Eating Questionnaire (TFEQ-r18) | Change in eating behaviors measured by Questionnaire: The Three-Factor Eating Questionnaire (TFEQ-r18) compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Minimum score of 18 and maximum score of 80 with higher scores associated with disinhibition, hunger, and decreased cognitive restraint. | 6 Month |
| Binary Outcomes: ≥25% change in %EWL | Compared between treatment arms by Pearson Chi-square test. | 6 Month |
| Incidence of esophagitis | Incidence of esophagitis identified by trained physician(s) to be compared between treatment arms by Pearson Chi-square test. | 6 Month |
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| 33011292 | Background | Sharaiha RZ, Hajifathalian K, Kumar R, Saunders K, Mehta A, Ang B, Skaf D, Shah S, Herr A, Igel L, Dawod Q, Dawod E, Sampath K, Carr-Locke D, Brown R, Cohen D, Dannenberg AJ, Mahadev S, Shukla A, Aronne LJ. Five-Year Outcomes of Endoscopic Sleeve Gastroplasty for the Treatment of Obesity. Clin Gastroenterol Hepatol. 2021 May;19(5):1051-1057.e2. doi: 10.1016/j.cgh.2020.09.055. Epub 2020 Oct 1. |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |