Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial (HAPCET)

Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial (HAPCET): A Single-center Randomized Controlled Trial

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: Apollo ESG; Device: Apollo ESG with ERBE HAPC

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group: ESG; Subjects will undergo ESG utilizing approved device alone	Device: Apollo ESG; Using only Apollo ESG as approved per label.
Experimental: Treatment Group: ESG + HAPC; Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.	Device: Apollo ESG with ERBE HAPC; Utilizing two approved devices in combination to assess durability of suturing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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).	6 month
Percentage of Glycated Hemoglobin (% HbA1c)	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis	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.	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	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.	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	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)	6 month
Binary Outcome: Incidence of Esophagitis	Compared between treatment arms by Pearson Chi-square test.	6 month

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Erbe Elektromedizin GmbH
• Investigators: Principal Investigator: Omar Ghanem, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Actual): August 2, 2024
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Estimated): October 23, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Hybrid APC; ESG
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: 22-001202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes