Treatment for Adiposity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic, Scottsdale, AZ
Adiposity+1 More
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This study is intended to investigate safety and feasibility of a new weight loss technique called endoscopic Gastric Mucosal Ablation (GMA) that does not require surgery, but can be achieved using an endoscopic procedure. Previous studies have suggested that weight loss after vertical sleeve gastrectomy (VSG) is partly due to the removal of normal stomach tissue suspected of having hormonal function. The study will investigate the minimally invasive treatment of obesity by means of argon plasma coagulation (APC) in combination with waterjet submucosal injection using HybridAPC. As primary objective total body weight loss (TBWL) will be determined as body weight difference at the 6 months follow up (FU) visit after the last treatment session in comparison to the body weight prior to the initial treatment. After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. If a participant is confirmed to be a suitable candidate additional tests will be performed prior to the first application of GMA to assess the health status of the participant prior to treatment. During the screening and baseline visit the medical history and the medications of the participant will be reviewed. After the treatments the participants will be followed for up to 12 months to assess the outcome of the GMA procedure.

Eligible Conditions

  • Adiposity
  • Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Adiposity

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 9 months

9 months
Total body weight loss

Trial Safety

Safety Progress

1 of 3

Other trials for Adiposity

Trial Design

0 Treatment Group

15 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 9 months
Closest Location: Mayo Clinic · Scottsdale, AZ
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1989First Recorded Clinical Trial
1 TrialsResearching Adiposity
2172 CompletedClinical Trials

Who is running the clinical trial?

Erbe USA IncorporatedOTHER
6 Previous Clinical Trials
514 Total Patients Enrolled
Erbe Elektromedizin GmbHLead Sponsor
4 Previous Clinical Trials
212 Total Patients Enrolled
Dilhana Badurdeen, MBBSPrincipal InvestigatorMayo Clinic, Jacksonville, Florida

Eligibility Criteria

Age 18 - 65 · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to avoid any use of weight loss medications or supplements.
You are a woman of childbearing potential
You are able to comply with study requirements and understand and sign the Informed Consent Form.
You have a history of failure to lose weight using conventional diet and lifestyle therapies.
You are between 22 and 60 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References