Your session is about to expire
← Back to Search
Weight Loss Device for Obesity
N/A
Waitlist Available
Led By Barham Abu Dayyeh, MD, MPH
Research Sponsored by USGI Medical
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 12 months
Awards & highlights
Study Summary
This trial is testing if a treatment can help people with obesity lose weight.
Who is the study for?
This trial is for adults aged 22-60 with a BMI of ≥35 and <40, experiencing obesity-related conditions like diabetes or hypertension. Participants must not have had weight loss surgery or be taking certain medications affecting weight. They should agree to follow dietary and exercise recommendations, use birth control if applicable, and live within 50 miles of the study site.Check my eligibility
What is being tested?
The study tests a medical device called g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors as an obesity treatment. It's part of a cross-over arm where participants receive alternative treatments during different phases to compare outcomes.See study design
What are the potential side effects?
While specific side effects are not listed, potential risks may include discomfort at the treatment site, digestive issues due to the intervention, and possible complications from the catheter placement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Percent TBWL at 12 months
Mean Percent TBWL at 3 months
Overall incidence of device and procedure related adverse events through 12 months
+2 moreSecondary outcome measures
Change from baseline at 12 months in Co-morbidities
Change from baseline at 12 months in Quality of Life Scores
Change from baseline at 12 months in liver function
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CrossoverExperimental Treatment1 Intervention
Continuation of POSE2.0 expansion study evaluating the safety and preliminary effectiveness of the Pose 2 procedure using the g-Cath EZ Suture Anchor Delivery Catheter as a primary weight loss intervention in the control arm, defined as crossover subjects from POSE2.0 Expansion Study.
Find a Location
Who is running the clinical trial?
USGI MedicalLead Sponsor
12 Previous Clinical Trials
840 Total Patients Enrolled
10 Trials studying Obesity
815 Patients Enrolled for Obesity
Barham Abu Dayyeh, MD, MPHPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
210 Total Patients Enrolled
2 Trials studying Obesity
210 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using or plan to use marijuana/cannabis.I haven't used any weight loss drugs for 6 months and won't use them for the next 12 months.I have had weight loss, stomach, or esophagus surgery in the past.I have a condition that makes it hard for medical tools to pass through my esophagus.I have a pancreatic condition.I have a history of autoimmune connective tissue disorders like rheumatoid arthritis.I use insulin or insulin derivatives to manage my diabetes.I have an active stomach or upper small intestine ulcer.I cannot stop taking aspirin, NSAIDs, or other stomach-irritating drugs for the study duration.I have no history of severe gut inflammation, bleeding disorders, or serious liver problems.I am a smoker but plan to quit within a year of joining.I have high blood pressure in the veins of my liver.I have signed and dated the consent form.I am between 22 and 60 years old.I have or had ulcers on my lower legs due to poor blood flow.I have chronic joint disease with cartilage loss and bone spurs.I do not have any severe illnesses affecting my whole body.I agree not to have weight loss surgery or liposuction for a year after joining the study.I cannot walk or have major difficulty moving around.I take diabetes medication or my fasting blood sugar is over 126 mg/dl.I am willing to possibly skip future weight loss surgeries due to unknown long-term effects.I have high cholesterol or triglycerides, or I'm on medication for it.My obesity is due to a hormonal or genetic condition, like untreated hypothyroidism.I have severe heartburn that affects my daily life and doesn't fully improve with medication.My BMI is between 35 and 40, and I have at least one obesity-related health issue.I haven't taken immunosuppressants or steroids in the last 6 months.I have a history of bleeding or clotting disorders.I have high blood pressure or am taking medication for it.I am a woman who is post-menopausal, surgically sterile, or will use birth control and have a negative pregnancy test.I have a history of slow stomach emptying or similar symptoms.I have severe symptoms of gastroparesis.I have had Type II Diabetes for over 11 years.I have a large hiatal hernia, confirmed by history or endoscopy.I have been diagnosed with sleep apnea based on a sleep study.
Research Study Groups:
This trial has the following groups:- Group 1: Crossover
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation still accessible to participants?
"Clinicaltrials.gov indicates that, while initially posted on January 19th 2023 and last updated June 30th 2023, this particular trial is not presently recruiting patients. Despite this fact, there are 986 other medical studies actively requesting participants at the moment."
Answered by AI
Could I partake in this research endeavor?
"To partake in this trial, participants must be between the ages of 22 and 60 as well as have obesity. Currently, the study is looking for 7 individuals to join their ranks."
Answered by AI
What goals are the researchers hoping to accomplish with this clinical trial?
"This clinical trial will evaluate its primary outcome over a 3-month period: mean percent total body weight loss at 12 months. Secondary objectives include change in quality of life measured with the IWQOL-Lite questionnaire, co-morbidity shifts from baseline to twelve months and liver function panel analysis during the same timeframe."
Answered by AI
Is participation in this clinical trial restricted to individuals aged 45 or under?
"According to this clinical trial's enrollment standards, the lowest age permitted is 22 and the highest age accepted for participation is 60."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger