Obesity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHybrid Argon Plasma Coagulation
Hybrid APC will be utilized to first ablate the gastric mucosa along the greater curve of the stomach.
PROCEDUREEndoscopic Sleeve Gastroplasty
Endoscopic full-thickness tissue acquisition and plication using 2-0 Prolene synthetic sutures via the Apollo ESG platform.
Sponsors
Erbe USA Incorporated
Erbe Elektromedizin GmbH
True You Weight Loss
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
1:1 allocation to experimental and control group using variable block randomization
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 21-65 2. BMI ≥ 30 and ≤40 kg/m² 3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure. 4. History of failure with non-surgical weight-loss methods. 5. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling. 6. Residing within a reasonable driving distance from the investigator's office (Cary, NC) and able to travel to the investigator to complete all routine follow-up visits as applicable 7. Ability to give informed consent. 8. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods. 9. Reliable access to wi-fi and/or internet services.
Exclusion criteria
1. History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy). 2. Prior gastrointestinal surgery with sequelae, i.e., obstruction, and/or adhesive peritonitis or known abdominal adhesions. 3. Prior open or laparoscopic bariatric surgery. 4. Prior surgery of any kind on the esophagus, stomach, or any type of hiatal hernia surgery. 5. Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer, or specific inflammatory disease such as Crohn's disease or celiac disease. 6. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses. 7. Gastrointestinal stromal tumors, history of premalignant gastric lesions (intestinal metaplasia), history of familial and nan-familial adenomatous syndromes. 8. A gastric mass or gastric polyps \> 1 cm in size. 9. A hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms. 10. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope. 11. Achalasia or any other severe esophageal motility disorder 12. Severe coagulopathy. 13. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C≥9. 14. Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy. 15. Chronic abdominal pain. 16. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation. 17. Hepatic insufficiency or cirrhosis. 18. Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing. 19. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist. 20. Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up. 21. Patients receiving daily prescribed treatment with high dose aspirin (\> 81mg daily), anti-inflammatory agents, anticoagulants, or other gastric irritants. 22. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication. 23. Patients who are pregnant or breast-feeding. 24. Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months. 25. Subjects with severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs. 26. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications. 27. Subjects who are taking corticosteroids, immunosuppressants, and narcotics. 28. Symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary artery disease. 29. Pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer. 30. Diagnosis of autoimmune connective tissue disorder (e.g. Systemic lupus erythematosus, scleroderma) or immunocompromised. 31. Specific diagnosed genetic disorder such as Prader Willi syndrome. 32. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating. 33. Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism. 34. At the discretion of the PI for subject safety 35. If minority inclusion population target of 10% has not been reached by the 90% enrollment mark (example 43 of 48 subjects), the remaining enrollments will be reserved for minority subjects (example 5 of 48 subjects).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Durability assessed by blinded physician(s) with expertise in endoscopic sleeve gastroplasty (ESG) procedures graded according to a priori standardized criteria. | 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| %EWL | 6 and 12 month | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis |
| Blood Pressure | 6 month | Systolic and diastolic blood pressure compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis |
| HbA1c percentage | 6 Month | 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 |
| Change in quality of life measured by Questionnaire: Short Form Health Survey (SF-36) | 6 Month | 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. |
| %TBWL | 6 Month | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis |
| Change in depression measured by Questionnaire: Patient Health Questionnaire (PHQ-9) | 6 Month | 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. |
| Change in eating behavior measured by Questionnaire: The Three-Factor Eating Questionnaire (TFEQ-r18) | 6 Month | 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. |
| Binary Outcomes: ≥25% change in %EWL | 6 Month | Compared between treatment arms by Pearson Chi-square test. |
| Incidence of esophagitis | 6 Month | Incidence of esophagitis identified by trained physician(s) to be compared between treatment arms by Pearson Chi-square test. |
| Change in quality of life measured by Questionnaire: Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | 6 Month | 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. |
Countries
United States
Outcome results
None listed