Clinical trial NCT05559866: Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial
Official title: Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial (HAPCET): a Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: ESG
Hybrid APC
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Erbe Elektromedizin GmbH
First posted: 2022-09-29
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Durability
timeFrame: 6 months
Secondary outcomes:
measure: %TBWL
timeFrame: 6 month
measure: %EWL
timeFrame: 6 and 12 month
measure: Blood Pressure
timeFrame: 6 month
measure: HbA1c
timeFrame: 6 month
measure: Questionnaire: SF-36
timeFrame: 6 month
measure: Questionnaire: IWQOL
timeFrame: 6 month
measure: Questionnaire: PHQ-9
timeFrame: 6 month
measure: Questionnaire: Eating Behavior
timeFrame: 6 month
measure: Binary Outcome: ≥25% reduction in %EWL
timeFrame: 6 month
measure: Binary Outcome: Incidence of esophagitis
timeFrame: 6 month
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Omar Ghanem, M.D.
role: PRINCIPAL_INVESTIGATOR
References: