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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 month
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 moreAwards & 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
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,337 Previous Clinical Trials
3,061,150 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I take medications that could be affected by how quickly my stomach empties.I cannot or will not take proton pump inhibitor medication.I agree to use birth control if I can have children.I have tried losing weight without surgery but it didn't work.I have a serious health issue that makes endoscopy risky for me.I have long-term stomach pain.I have liver problems or cirrhosis.I am currently taking corticosteroids, immunosuppressants, or narcotics.I have an autoimmune disorder or a weakened immune system.I have had GI surgery, but it was not a simple gallbladder or appendix removal.I have had stomach or intestine surgery that caused complications like blockage or internal scar tissue.I have heart problems like heart failure, irregular heartbeat, or unstable heart disease.I have had weight loss surgery before.I do not have conditions that could cause serious stomach or intestine bleeding.I have a severe swallowing disorder.I have diabetes that requires insulin or my HgbA1C is 9 or higher.I have severe movement problems in my digestive system.I have a serious lung condition like severe COPD, pneumonia, or lung cancer.I have been diagnosed with a specific genetic disorder.I have a hormone-related condition that affects my weight.I live close enough to the doctor's office to attend all my appointments.I do not have severe heart, lung, or serious diseases.I have a large hiatal hernia or severe acid reflux that doesn't get better with treatment.I have a structural issue in my esophagus or throat.I have a severe blood clotting disorder.I have not taken any weight-loss medications or therapies in the last 6 months.I am on daily medication like high dose aspirin or blood thinners.I do not have severe GI tract conditions like Crohn's or celiac disease.I have had surgery on my esophagus, stomach, or for a hiatal hernia.I have a stomach mass or polyps larger than 1 cm.You must be willing to follow strict dietary restrictions for the rest of your life.I have tried losing weight without surgery but it didn't work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group: ESG + HAPC
- Group 2: Control Group: ESG
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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