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Combined Ablation and ESG for Obesity
N/A
Waitlist Available
Led By Christopher E McGowan, MD, MSCR
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 1, month 2, month 3, month 4, month 5, month 6, month 7, month 8, month 9, month 10, month 11, month 12, month 13, month 14, month 15, month 16, month 17, and month 18
Awards & highlights
No Placebo-Only Group
Summary
This trial will explore if combining a new procedure (FA) with ESG, can lead to improved satiation, reduced ghrelin and greater weight loss than traditional ESG alone.
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 access the internet, travel to Cary, NC, and not be on certain medications or have conditions affecting stomach function. Pregnant individuals or those planning pregnancy during the study are excluded.
What is being tested?
The trial tests if fundic ablation (FA) followed by endoscopic sleeve gastroplasty (ESG) leads to better appetite control and more weight loss than ESG alone. FA targets ghrelin, a hormone that increases appetite; this combination could improve satiation and reduce body weight.
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, changes in digestion or bowel habits due to alterations in stomach function from the procedures, as well as possible reactions related to thermal injury caused by FA.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 1, month 2, month 3, month 4, month 5, month 6, month 7, month 8, month 9, month 10, month 11, month 12, month 13, month 14, month 15, month 16, month 17, and month 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 1, month 2, month 3, month 4, month 5, month 6, month 7, month 8, month 9, month 10, month 11, month 12, month 13, month 14, month 15, month 16, month 17, and month 18
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Daily Eats: Measuring Daily Eating Factors (DAILY EATS)
Change from Baseline in Fasting Plasma Ghrelin Levels
Change from Baseline in Gastroparesis Cardinal Symptom Index (GCSI)
+3 moreSecondary study objectives
Rate of safety and adverse events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Gastric Fundic Ablation plus Endoscopic Sleeve GastroplastyExperimental Treatment3 Interventions
Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty
Find a Location
Who is running the clinical trial?
True You Weight LossLead Sponsor
4 Previous Clinical Trials
358 Total Patients Enrolled
4 Trials studying Obesity
358 Patients Enrolled for Obesity
Christopher E McGowan, MD, MSCRPrincipal InvestigatorCEO/ Medical Director
1 Previous Clinical Trials
48 Total Patients Enrolled
1 Trials studying Obesity
48 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking buspirone or mirtazapine.I am under 21 years old.I can travel to and from Cary, North Carolina for the trial.I am older than 65.I am between 21 and 65 years old.I am able to and have agreed to participate in this study.I am on long-term blood thinners.I am not taking medications that affect how my stomach empties.Your body mass index (BMI) is either very high (30 kg/m² or more) or very low (50 kg/m² or less).I have had surgery on my stomach before.I cannot stop taking my non-steroidal anti-inflammatory medications for the study.I am currently taking medication to help me lose weight.I have a history of stomach or bowel issues like IBS.I am not on medications affecting hormones like insulin or growth hormone.My A1c is over 7.0, or I have symptoms or a diagnosis of gastroparesis.
Research Study Groups:
This trial has the following groups:- Group 1: 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.
Obesity Patient Testimony for trial: Trial Name: NCT05578703 — N/A