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Procedure
Combined Fundic Ablation and ESG for Obesity (AW2 Trial)
N/A
Waitlist Available
Research Sponsored by True You Weight Loss
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects aged 21-65
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, month 1, month 2, month 3, month 4, month 6, month 7, month 8, month 9, month 10, month 11, month 12
Awards & highlights
AW2 Trial Summary
This trial is testing a new procedure to reduce appetite, help people feel full, and lead to greater weight loss than traditional methods.
Who is the study for?
This trial is for adults aged 21-65 with a BMI of 30-50 who have tried and failed to lose weight through dieting. They must be able to travel to Cary, North Carolina, have internet access, and not be pregnant or planning pregnancy during the study. Exclusions include prior stomach surgery, certain medical conditions like uncontrolled diabetes or gastroparesis, use of specific medications affecting digestion or blood clotting, and allergies to milk/soy.Check my eligibility
What is being tested?
The trial tests a combined procedure for weight loss: fundic ablation (FA) plus endoscopic sleeve gastroplasty (ESG). FA uses thermal injury on the stomach's gastric fundus to reduce ghrelin hormone levels that increase appetite. ESG reshapes the stomach. Together they aim to enhance satiation and promote more weight loss than ESG alone.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, changes in bowel habits or digestive issues due to alterations in appetite control mechanisms from FA and ESG procedures. There might also be risks associated with sedation required for these procedures.
AW2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 65 years old.
AW2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1, month 1, month 2, month 3, month 4, month 6, month 7, month 8, month 9, month 10, month 11, month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, month 1, month 2, month 3, month 4, month 6, month 7, month 8, month 9, month 10, month 11, month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Adverse Events
Rate of Safety Complications
Secondary outcome measures
Percent Change in Total Body Weight Loss (TBWL) from Baseline
AW2 Trial Design
1Treatment groups
Experimental Treatment
Group I: Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve GastroplastyExperimental Treatment3 Interventions
Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the same endoscopic session
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Who is running the clinical trial?
True You Weight LossLead Sponsor
2 Previous Clinical Trials
58 Total Patients Enrolled
2 Trials studying Obesity
58 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 21 and 65 years old.I am currently taking medication to help me lose weight.I have a history of stomach or bowel problems like IBS.I am not taking buspirone or mirtazapine.I can travel to and from Cary, North Carolina easily.I cannot stop taking my anti-inflammatory medications for the study.My blood sugar control is poor, or I have symptoms/diagnosis of gastroparesis.I am unable to give consent for the study due to my current condition.I am under 21 years old.I am older than 65.You are allergic to milk or soy.You have a history of having problems with eating.I am on long-term blood thinners.You have tried to lose weight through dieting in the past but were not successful.I am taking medication that affects my hormone levels.I have had surgery on my stomach before.I am not taking medications that affect how my stomach empties.
Research Study Groups:
This trial has the following groups:- Group 1: Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty
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 open to individuals who are over fifty years of age?
"The guidelines for this clinical trial state that the minimum age of eligibility is 21, and participants must not exceed 65 years old."
Answered by AI
Do I fulfill the criteria to be a viable participant in this trial?
"This clinical trial is accepting 10 participants who are obese and between the ages of 21-65."
Answered by AI
Are participants still being enrolled in this trial?
"As per the details on clinicaltrials.gov, this particular research is no longer accepting candidates; having been initially posted on September 14th 2023 and then updated for the last time in August 8th 2023. Despite that there are 1,110 other trials actively recruiting participants at present."
Answered by AI
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