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Hybrid Argon Plasma Coagulation + Endoscopic Sleeve Gastroplasty for Obesity (HAPCET Trial)

N/A
Waitlist Available
Led By Omar Ghanem, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 month
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a combination of two procedures to help people lose weight. It targets individuals with a BMI between 30 and 40 who haven't been able to lose weight through non-surgical methods. The treatment works by making the stomach smaller and removing extra tissue, which helps people eat less and feel full sooner.

Who is the study for?
This trial is for adults with obesity (BMI between 30 and 40) who haven't succeeded in losing weight through non-surgical methods. They must be willing to follow strict lifelong dietary changes, live near the investigator's office for follow-ups, and women of childbearing age should use birth control. Exclusions include those with serious heart conditions, prior GI surgeries, insulin-dependent diabetes, psychological issues affecting lifestyle changes, or severe diseases.
What is being tested?
The study compares the effectiveness of two procedures: Hybrid Argon Plasma Coagulation combined with Endoscopic Sleeve Gastroplasty (HAPC+ESG) versus ESG alone. The goal is to see which method is better at helping participants lose weight and improve health problems related to obesity.
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, abdominal pain, nausea or vomiting after the procedure. There could also be risks associated with sedation used during endoscopy such as allergic reactions or breathing difficulties.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Durability
Secondary study objectives
%EWL
%TBWL
Binary Outcome: Incidence of esophagitis
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Group: ESG + HAPCExperimental Treatment1 Intervention
Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.
Group II: Control Group: ESGActive Control1 Intervention
Subjects will undergo ESG utilizing approved device alone

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,060,999 Total Patients Enrolled
87 Trials studying Obesity
9,110 Patients Enrolled for Obesity
Erbe Elektromedizin GmbHIndustry Sponsor
12 Previous Clinical Trials
577 Total Patients Enrolled
4 Trials studying Obesity
93 Patients Enrolled for Obesity
Omar Ghanem, M.D.Principal InvestigatorMayo Clinic

Media Library

Treatment Group: ESG + HAPC Clinical Trial Eligibility Overview. Trial Name: NCT05559866 — N/A
Obesity Research Study Groups: Treatment Group: ESG + HAPC, Control Group: ESG
Obesity Clinical Trial 2023: Treatment Group: ESG + HAPC Highlights & Side Effects. Trial Name: NCT05559866 — N/A
Treatment Group: ESG + HAPC 2023 Treatment Timeline for Medical Study. Trial Name: NCT05559866 — N/A
~8 spots leftby Dec 2025