Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05559866
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 18, 2022
Status verified
Oct 2025
Primary completion
Aug 2, 2024
Completion
Jan 17, 2025

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Control Group: ESG
    Subjects will undergo ESG utilizing approved device alone
  • Experimental: Treatment Group: ESG + HAPC
    Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.

Primary Outcome Measure

Durability [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic RochesterRochesterMinnesota55905-

Find similar trials in Rochester, MN

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Mayo Clinic Rochester· Rochester, MN

Related Studies