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Procedure
g-Cath EZ for Obesity
N/A
Waitlist Available
Led By Barham Abu Dayyeh, MD
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 2 & 6 months
Awards & highlights
Study Summary
This trial studies a new treatment for obesity. Four centers are participating in an open trial with two groups to test its effectiveness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 & 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 & 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary weight loss intervention
Secondary outcome measures
Changes in gastric emptying
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: g-Cath EZExperimental Treatment2 Interventions
Placement of Snowshoe suture anchors from g-Cath EZ Delivery Catheters, in a defined pattern in the mid and distal portions of the stomach, along with a moderate intensity diet & exercise program, to treat primary obesity.
Group II: Diet and ExerciseActive Control1 Intervention
A moderate intensity diet & exercise program to treat primary obesity
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Who is running the clinical trial?
USGI MedicalLead Sponsor
12 Previous Clinical Trials
807 Total Patients Enrolled
10 Trials studying Obesity
782 Patients Enrolled for Obesity
Barham Abu Dayyeh, MDPrincipal InvestigatorMayo
4 Previous Clinical Trials
244 Total Patients Enrolled
1 Trials studying Obesity
39 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- If you smoke, you need to have a plan to quit smoking within a year after joining the study.You currently have a stomach or intestinal problem such as an ulcer or erosion.You have a narrow or blocked esophagus that would make it difficult to perform certain medical procedures.You have a history of gastroparesis or symptoms that suggest problems with the movement of food through your digestive system (like difficulty swallowing or issues with the muscles in your esophagus and stomach).You have or had mental health conditions like psychosis, bipolar disorder, or obsessive-compulsive disorder, which were assessed by a doctor or psychologist before you joined the study.Your score on a depression test is 12 or higher, or you have uncontrolled depression even after being assessed by a psychologist and doctor before joining the study.You have a history of inflammation in your digestive system, problems with blood clotting, or liver problems.You have or have had leg ulcers caused by poor blood flow in the veins.You have a big hiatal hernia, which means your stomach bulges up through an opening in your diaphragm.You have been diagnosed with rheumatoid arthritis, scleroderma, lupus, or other autoimmune connective tissue disorder in the past.You have a history of severe allergic reactions or hypersensitivity to the drugs or materials used in the study.You have had previous surgery on your stomach or esophagus to help with weight loss.You have moderate to severe symptoms in at least one of the 9 identified symptoms of gastroparesis.You have chronic joint disease, which means the cartilage in your joints is wearing down and new bone is growing around the edges of your joints.You have moderate gastro-esophageal reflux disease (GERD) that causes you severe discomfort and affects your daily activities, even with medication.You have high blood pressure in the portal vein or swollen blood vessels in your digestive tract.
Research Study Groups:
This trial has the following groups:- Group 1: g-Cath EZ
- Group 2: Diet and Exercise
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.
Do the prerequisites for this experiment extend to those of a younger age bracket?
"This trial requires patients to be between the ages of 22 and 60. For those under 18 or over 65, there are 198 studies for the former group and 611 trials for the latter cohort."
Answered by AI
What locations are administering this trial within the state?
"This clinical trial is hosted in 8 different locations, including Mayo Clinic of Rochester, University of Miami Miller School of Medicine, and Brigham and Women's Hospital."
Answered by AI
For whom is enrollment in this study eligible?
"In order to qualify, prospective participants must range in age from 22 to 60 and have a Body Mass Index that classifies them as obese. 40 individuals are needed for this clinical trial."
Answered by AI
Are any new participants still being accepted for this clinical trial?
"Accessing clinicaltrials.gov reveals that this medical trial, which was initially posted in October of 2019 and last updated on May 17th 2023 is no longer enrolling patients. However, there are still 986 other trials currently seeking volunteers."
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