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Device

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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

Rate of safety and adverse events

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

Do I qualify?Apply below to find out

Find a Location

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

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

Apollo ESG (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05578703 — N/A

Obesity Research Study Groups: Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty

Obesity Clinical Trial 2023: Apollo ESG Highlights & Side Effects. Trial Name: NCT05578703 — N/A

Apollo ESG (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05578703 — N/A

Obesity Patient Testimony for trial: Trial Name: NCT05578703 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For this particular test, are older patients being considered for treatment?

"For this particular study, only patients that are 21 to 65 years old can participate. However, there are other clinical trials available for both age groups outside of the specified parameters."

Answered by AI

How many patients can join this clinical trial at most?

"Yes, the study is still looking for participants and was last updated on 11/14/2022. The trial originally posted on 11/9/2022 seeks 10 patients from 1 site."

Answered by AI

How can I sign up to be a part of this important research?

"The principal investigators are looking for around 10 participants that fit the following inclusion criteria: They must be between 21 and 65 years old and suffer from obesity."

Answered by AI

Are participants being enrolled in this trial at present?

"That is correct, the information available on clinicaltrials.gov says that this study is recruiting patients right now. This trial was first posted on November 9th, 2022 and was last updated on November 14th, 2022. They are looking for 10 more patients at 1 site."

Answered by AI

Who else is applying?

What state do they live in?

North Carolina

What site did they apply to?

True You Weight Loss

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have tried for years to lose weight and almost barely ever eat anything. I constantly gain weight and have tried metformin with very little success. I am unable to exercise much due to other health conditions.

PatientReceived 2+ prior treatments