Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial

Not Applicable

Completed

Conditions: Obesity

Registration Number: NCT05559866

Lead Sponsor: Mayo Clinic

Brief Summary: This study is being done to evaluate the safety and effectiveness of combined Hybrid Argon Plasma Coagulation (HAPC) and Endoscopic Sleeve Gastroplasty (ESG) for weight loss and improvement in obesity-related co-morbidities compared to ESG alone in participants with a BMI ≥ 30 and ≤40 kg/m² who have failed to achieve and maintain weight loss with a non-surgical program.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 45

Inclusion Criteria

BMI ≥ 30 and ≤40 kg/m²
Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
History of failure with non-surgical weight-loss methods.
Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling.
Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow-up visits.
Ability to give informed consent.
Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.

Exclusion Criteria

History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy).
Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
Prior open or laparoscopic bariatric surgery.
Prior surgery of any kind on the esophagus, stomach, or any type of hiatal hernia surgery.
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.
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.
Gastrointestinal stromal tumors, history of premalignant gastric lesions (intestinal metaplasia), history of familial and nan-familial adenomatous syndromes.
A gastric mass or gastric polyps > 1 cm in size.
A hiatal hernia > 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
Achalasia or any other severe esophageal motility disorder
Severe coagulopathy.
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.
Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy.
Chronic abdominal pain.
Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation.
Hepatic insufficiency or cirrhosis.
Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.
Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up.
Patients receiving daily prescribed treatment with high dose aspirin (> 81mg daily), anti-inflammatory agents, anticoagulants, or other gastric irritants.
Patients who are unable or unwilling to take prescribed proton pump inhibitor medication.
Patients who are pregnant or breast-feeding.
Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months.
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.
Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications.
Subjects who are taking corticosteroids, immunosuppressants, and narcotics.
Symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary artery disease.
Pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer.
Diagnosis of autoimmune connective tissue disorder (e.g. Systemic lupus erythematosus, scleroderma) or immunocompromised.
Specific diagnosed genetic disorder such as Prader Willi syndrome.
Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.
At the discretion of the PI for subject safety
If minority inclusion population target of 10% has not been reached by the 90% enrollment mark (example 21 of 24 subjects), the remaining enrollments will be reserved for minority subjects (example 3 of 24 subjects).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Durability	6 months	The primary outcomes are durability of plications and endoscopic sutures on repeat endoscopy at 6 months, in the two randomized arms. Endoscopic scale runs from 0 to 3. A lower score indicates less durability and a higher score indicates greater durability.

Secondary Outcome Measures

Name	Time	Method
Percent Total Body Weight Loss (%TBWL)	6 month	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Percent total body weight loss was analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). Total body weight loss is calculated as follows: Total Body Weight Loss (%) = \[ (Starting Weight - Current Weight) / Starting Weight \] × 100
Percent Excess Weight Loss (%EWL)	6 and 12 month	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Percent excess weight loss was analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). % EWL = (actual weight lost / excess body weight) x 100 Where excess body weight represents the difference in starting weight and ideal weight (weight corresponding to a body mass index of 25 kg/m\^2)
Blood Pressure	6 month	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Blood pressure scores analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index).
Percentage of Glycated Hemoglobin (% HbA1c)	6 month	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis
Questionnaire: Short Form (36) Health Survey [SF-36]	6 month	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. 8 quality of life domains assessed, domains scores range 0-100 with a lower score indicating a worse outcome, and a higher score indicating a better outcome.
Questionnaire: Impact of Weight on Quality of Life (IWQOL)	6 month	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. 5 quality of life domains are scored, a higher score indicates higher quality of life relative to that domain and lower score indicates worse quality of life relative to that domain. Physical function domain (11 items scored 1-5) total scores ranging 11-55 Self-esteem domain (seven items scored 1-5) total scores ranging 7-35 Sexual life domain (four items each scored 1-5) total scores ranging 4-20 Public distress domain (five items each scored 1-5) total scores ranging 5-25 Work-related domain (four items each scored 1-5) total scores ranging 4-20
Questionnaire: Patient Health Questionnaire-9 (PHQ-9)	6 month	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Score range 0-27, with a higher score indicating more severe symptoms and a lower score indicating less severe or no symptoms.
Questionnaire: Eating Behavior	6 month	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Scored across three behavioral domains, higher scores in each subscale indicate a greater tendency towards that particular eating behavior. Cognitive Restraint Score range 6-28 Uncontrolled Eating Score range 9-36 Emotional Eating Score range 3-12
Binary Outcome: ≥25% Reduction in Percent Excess Weight Loss (%EWL)	6 month	Compared between treatment arms by Pearson Chi-square test. % EWL = (actual weight lost / excess body weight) x 100 Where excess body weight represents the difference in starting weight and ideal weight (weight corresponding to a body mass index of 25 kg/m\^2)
Binary Outcome: Incidence of Esophagitis	6 month	Compared between treatment arms by Pearson Chi-square test.