Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial

Obesity Clinical Trial

— HAPCET  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05559866
• Other study ID #: 22-001202
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 18, 2022
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: January 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Apollo ESG with ERBE HAPC
Utilizing two approved devices in combination to assess durability of suturing.
• Apollo ESG
Using only Apollo ESG as approved per label.

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Erbe Elektromedizin GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Durability	The primary outcomes are durability of plications and endoscopic sutures on repeat endoscopy at 6 months, in the two randomized arms.	6 months
Secondary	%TBWL	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis	6 month
Secondary	%EWL	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis	6 and 12 month
Secondary	Blood Pressure	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis	6 month
Secondary	HbA1c	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis	6 month
Secondary	Questionnaire: SF-36	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis	6 month
Secondary	Questionnaire: IWQOL	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis	6 month
Secondary	Questionnaire: PHQ-9	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis	6 month
Secondary	Questionnaire: Eating Behavior	Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis	6 month
Secondary	Binary Outcome: =25% reduction in %EWL	Compared between treatment arms by Pearson Chi-square test.	6 month
Secondary	Binary Outcome: Incidence of esophagitis	Compared between treatment arms by Pearson Chi-square test.	6 month

External Links

•   Mayo Clinic Clinical Trials