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NCT05559866 | Active, not recruiting | Obesity

Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial
Sponsor:

Mayo Clinic

Information provided by (Responsible Party):

Barham K. Abu Dayyeh, M.D.

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.

Condition or disease

Obesity

Intervention/treatment

Apollo ESG with ERBE HAPC

Apollo ESG

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 24 participants
Masking : None (Open Label)
Primary Purpose : Health Services Research
Official Title : Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial (HAPCET): A Single-center Randomized Controlled Trial
Actual Study Start Date : November 18, 2022
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : January 2025
Arm Intervention/treatment

Active Comparator: Control Group: ESG

Subjects will undergo ESG utilizing approved device alone

Device: Apollo ESG

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
Ages Eligible for Study: 21 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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).
Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial

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Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial

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Locations

Not yet recruiting

United States, Minnesota

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905