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Endoscopic Gastric Mucosal Ablation for Obesity (COMET Trial)
N/A
Waitlist Available
Led By Dilhana Badurdeen, MBBS
Research Sponsored by Erbe Elektromedizin GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Summary
This trial is testing a new non-surgical weight loss method called GMA for obese people. It uses a tube with a camera to treat the stomach lining with argon gas and waterjet, which helps reduce hunger hormones.
Who is the study for?
This trial is for adults aged 22-60 with a BMI of 30 to ≤45, who have unsuccessfully tried diet and lifestyle weight loss methods. They must not have had bariatric surgery or therapy before, agree to avoid weight loss drugs during the study, use contraception if applicable, and be able to follow the study's requirements.
What is being tested?
The trial tests a new non-surgical weight loss method called endoscopic Gastric Mucosal Ablation (GMA) using Hybrid Argon Plasma Coagulation (HAPC). Participants will undergo this procedure and their total body weight loss will be tracked over six months.
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, abdominal pain, nausea, risks associated with endoscopy such as bleeding or infection, and possible changes in bowel habits or stomach function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total body weight loss
Trial Design
1Treatment groups
Experimental Treatment
Group I: Gastric mucosal ablationExperimental Treatment1 Intervention
Participants receive submucosal injection followed by ablation of gastric mucosa using Hybrid Argon Plasma Coagulation (HAPC)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for obesity, such as Endoscopic Gastric Mucosal Ablation (GMA), work by reducing stomach volume or altering hormonal signals that regulate hunger and satiety. GMA specifically uses Argon Plasma Coagulation (APC) combined with waterjet submucosal injection to ablate the gastric mucosa, potentially affecting hormones like ghrelin that stimulate appetite.
By decreasing ghrelin levels, these treatments can help reduce hunger and promote weight loss. Understanding these mechanisms is important for obesity patients as it shows how these treatments target both physical and hormonal aspects of appetite control, aiding in effective weight management.
Use of intragastric balloons for weight reduction. An experimental study.Bariatric Radioembolization: A Pilot Study on Technical Feasibility and Safety in a Porcine Model.The effect of exogenous GLP-1 on food intake is lost in male truncally vagotomized subjects with pyloroplasty.
Use of intragastric balloons for weight reduction. An experimental study.Bariatric Radioembolization: A Pilot Study on Technical Feasibility and Safety in a Porcine Model.The effect of exogenous GLP-1 on food intake is lost in male truncally vagotomized subjects with pyloroplasty.
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Who is running the clinical trial?
Erbe Elektromedizin GmbHLead Sponsor
12 Previous Clinical Trials
586 Total Patients Enrolled
4 Trials studying Obesity
102 Patients Enrolled for Obesity
Erbe USA IncorporatedOTHER
11 Previous Clinical Trials
1,236 Total Patients Enrolled
4 Trials studying Obesity
80 Patients Enrolled for Obesity
Dilhana Badurdeen, MBBSPrincipal InvestigatorMayo Clinic, Jacksonville, Florida
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to take any weight loss drugs or supplements during the study.I am treating my diabetes without using SU, biguanides, or SGLT-2 inhibitors.I haven't changed my diabetes medication or doses in the last 12 weeks.I have a history of slow stomach emptying due to diabetes.I have active hepatitis or liver disease.I have not had a stomach or intestinal illness in the last week.I have a history of conditions like irritable bowel syndrome or Crohn's disease.I often experience stomach pain, nausea, or vomiting after eating.I have a known disorder of the esophagus that affects my swallowing or causes chest pain or drug-resistant reflux.I have long-term stomach problems like pain, nausea, or feeling full quickly.I agree to use birth control as a woman who can become pregnant.I currently have an infection in my body.I have never had weight loss surgery or non-surgical weight loss procedures.I am between 22 and 60 years old.I am not taking medications that affect stomach movement.I have not had any cancer except for treated skin cancer in the last 5 years.I am currently taking weight loss medications.I have been diagnosed with Multiple Endocrine Neoplasia type 1.My kidneys do not work well (eGFR <45).I cannot undergo surgery or be given general anesthesia.My thyroid condition is stable, and I've been on the same medication dose for at least 6 weeks.I am currently on blood thinners.I need insulin from outside my body to manage my diabetes.My BMI is between 30 and 45, and I have health issues related to obesity.I have an autoimmune disease like celiac or lupus.I have had diabetic ketoacidosis or a severe diabetic coma before.I have tried and failed to lose weight through diet and exercise.I have a health issue that prevents me from undergoing an endoscopy.I have an active H. pylori infection but am receiving treatment.I've had severe low blood sugar needing someone's help more than once last year.My BMI is between 30 and 45, and I may have health issues related to my weight.I have a known stomach condition such as an ulcer, hernia, or cancer.I have not taken steroid pills for more than 10 days in the last 3 months.I must use anti-inflammatory drugs that I cannot stop for at least 4 weeks after a procedure.I have had surgery on my upper stomach or other related procedures.I have a history of bleeding disorders or stomach/intestinal bleeding issues.I have a condition affecting my esophagus that could make certain medical procedures risky.I have used insulin for more than a month, not for gestational diabetes.My diabetes treatment hasn't changed in the last 3 months.I have not had a heart attack, heart failure, or stroke in the last 6 months.I have a weakened immune system due to conditions like organ transplant, recent cancer treatment, low white blood cell count, or HIV.I am between 22 and 60 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Gastric mucosal ablation
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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