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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
45
Utilizing two approved devices in combination to assess durability of suturing.
Using only Apollo ESG as approved per label.
Mayo Clinic Rochester
Rochester, Minnesota, United States
Durability
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.
Time frame: 6 months
Percent Total Body Weight Loss (%TBWL)
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
Time frame: 6 month
Percent Excess Weight Loss (%EWL)
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)
Time frame: 6 and 12 month
Blood Pressure
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).
Time frame: 6 month
Percentage of Glycated Hemoglobin (% HbA1c)
Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis
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Time frame: 6 month
Questionnaire: Short Form (36) Health Survey [SF-36]
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.
Time frame: 6 month
Questionnaire: Impact of Weight on Quality of Life (IWQOL)
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
Time frame: 6 month
Questionnaire: Patient Health Questionnaire-9 (PHQ-9)
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.
Time frame: 6 month
Questionnaire: Eating Behavior
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
Time frame: 6 month
Binary Outcome: ≥25% Reduction in Percent Excess Weight Loss (%EWL)
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)
Time frame: 6 month
Binary Outcome: Incidence of Esophagitis
Compared between treatment arms by Pearson Chi-square test.
Time frame: 6 month