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Endoscopic Gastric Mucosal Ablation for Obesity (COMET Trial)
COMET Trial Summary
This trial is investigating a new, minimally-invasive weight loss technique that doesn't require surgery. The study will assess the safety and feasibility of the treatment and will follow participants for up to 12 months to determine the outcome of the procedure.
COMET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOMET Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COMET Trial Design
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Who is running the clinical trial?
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- 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 tried and failed to lose weight through diet and exercise.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 never had weight loss surgery or non-surgical weight loss procedures.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 agree not to take any weight loss drugs or supplements during the study.I agree to use birth control as required.I am between 22 and 60 years old.
- Group 1: Gastric mucosal ablation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is there currently an open call for participants in this research?
"Based on clinicaltrials.gov, this particular medical trial is not currently recruiting patients. The investigation was initially posted in December of 2022 and last amended in August of the same year. Although no longer recruiting participants now, there are 957 other trials actively searching for volunteers at present."
Does this research endeavor allow for geriatric participation?
"Patients aged 22 to 60 are eligible for participation in this clinical trial. Conversely, there exist 202 trials available specifically for individuals under 18 years old and 596 endeavours that cater to those over 65."
What are the prerequisites for participating in this research?
"In order to be accepted into this study, potential volunteers must have a body composition indicative of adiposity and fall between the ages of 22 to 60. The current enrollment quota is 15 participants."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Mayo Clinic: < 48 hours
Average response time
- < 2 Days
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