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Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial

NCT05559866 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-10-23

Study results available
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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

Interventions

DEVICE

Apollo ESG with ERBE HAPC

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

DEVICE

Apollo ESG

Using only Apollo ESG as approved per label.

Sponsors & Collaborators

  • Erbe Elektromedizin GmbH

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Omar Ghanem, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-18
Primary Completion
2024-08-02
Completion
2025-01-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05559866 on ClinicalTrials.gov