Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial

NCT05559866 | Completed Results FDA Device

• 1 other identifier: 22-001202
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

ESG; Hybrid APC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Percent Total Body Weight Loss (%TBWL)

  6 month

• Percent Excess Weight Loss (%EWL)

  6 and 12 month

• Blood Pressure

  6 month

• Percentage of Glycated Hemoglobin (% HbA1c)

  6 month

• Questionnaire: Short Form (36) Health Survey [SF-36]

  6 month

Study Arms (2)

Control Group: ESG

ACTIVE COMPARATOR

Subjects will undergo ESG utilizing approved device alone

Device: Apollo ESG

Treatment Group: ESG + HAPC

EXPERIMENTAL

Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.

Device: Apollo ESG with ERBE HAPC

Interventions

Apollo ESG with ERBE HAPC DEVICE

Utilizing two approved devices in combination to assess durability of suturing.

Treatment Group: ESG + HAPC

Apollo ESG DEVICE

Using only Apollo ESG as approved per label.

Control Group: ESG

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Erbe Elektromedizin GmbH: collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This is a pilot trial and therefore no formal power analysis was performed.

Results Point of Contact

• Title: Dr. Omar Ghanem
• Organization: Mayo Clinic

ghanem.omar@mayo.edu

507-284-2095

Study Officials

• Omar Ghanem, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: November 18, 2022
• Primary Completion: August 2, 2024
• Study Completion: January 17, 2025
• Last Updated: October 23, 2025
• Results First Posted: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)