Gastric Fundal Mucosal Ablation for Obesity

(MAINTAIN Trial)

Overseen By Christopher McGowan, MD, MSCR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Christopher McGowan

Must not be taking: Anticoagulants, NSAIDs, Weight loss drugs

Disqualifiers: Diabetes, Stomach manipulation, Active disordered eating, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 session

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores Gastric Fundal Mucosal Ablation (GFMA) to determine its effectiveness in helping individuals maintain weight loss after discontinuing certain weight-loss medications, specifically semaglutide or tirzepatide. The trial targets adults who have lost more than 10% of their body weight using these medications and plan to stop them. It is suitable for those who have not regained more than half of the lost weight and do not have diabetes. The trial seeks to determine if GFMA can help maintain weight loss after stopping these medications. Participants will undergo a single GFMA session performed by a specialist. As an unphased trial, this study provides a unique opportunity to explore innovative weight maintenance strategies.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. Participants must discontinue semaglutide or tirzepatide and cannot use medications that affect blood clotting, certain hormones, or those known to induce weight loss during the study.

What prior data suggests that gastric fundal mucosal ablation is safe for obesity treatment?

Research has shown that Gastric Fundal Mucosal Ablation (GFMA) is generally safe. In earlier studies, most patients experienced only mild side effects, such as nausea or stomach cramps, which resolved after a day or two. Importantly, no serious problems have been reported. This suggests that GFMA is usually well-tolerated, making it a promising option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Gastric Fundal Mucosal Ablation (GFMA) is unique because it offers a new approach to treating obesity by directly targeting the stomach lining through an endoscopic procedure. Unlike traditional options like dietary changes, medications, or surgical interventions that often involve significant lifestyle changes or invasive techniques, GFMA is minimally invasive and performed in a single session. Researchers are excited about GFMA because it could provide a quicker, less invasive alternative to existing obesity treatments, potentially improving patient outcomes with fewer side effects.

What evidence suggests that gastric fundal mucosal ablation is effective for obesity?

Research has shown that Gastric Fundal Mucosal Ablation (GFMA) can aid weight loss in adults with obesity. One study found that GFMA promotes weight loss by affecting the stomach area that regulates hunger, leading to earlier satiety. Importantly, data from the ABLATE I & II trials demonstrated that GFMA, when combined with another procedure, resulted in an average total body weight loss. In this trial, participants will undergo GFMA after discontinuing GLP-1 therapy. These findings suggest that GFMA could effectively manage weight after stopping GLP-1 medications. Overall, the evidence supports its potential to help maintain weight loss. ^{1 2 3 6 7}

Who Is on the Research Team?

Christopher McGowan, MD

Principal Investigator

True You Weight Loss

Are You a Good Fit for This Trial?

The MAINTAIN trial is for adults with obesity who have lost more than 10% of their weight using GLP-1 therapy like semaglutide or tirzepatide and are planning to stop taking these medications. The study aims to see if a procedure called GFMA can help maintain their weight loss after stopping the medication.

Inclusion Criteria

Willing and able to participate in the study procedures

Access to internet

Reliable transportation

Exclusion Criteria

Active disordered eating

Unwillingness to abstain from the use of tobacco during the study duration

Patients who are pregnant, who plan to become pregnant during study duration, or patients of child-bearing potential who refuse effective birth control methods (as approved by PI)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events, appetite, BMI, weight recurrence, and quality of life

12 months

Monthly assessments

What Are the Treatments Tested in This Trial?

Interventions

• Gastric Fundal Mucosal Ablation (GFMA)

Trial Overview This clinical trial tests Gastric Fundal Mucosal Ablation (GFMA), a procedure designed to help individuals maintain their weight loss achieved through GLP-1 therapy, even after they've stopped taking the GLP-1 drugs.

How Is the Trial Designed?

Group I: Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy Experimental Treatment 1 Intervention

Subjects will undergo endoscopic Gastric Fundal Mucosal Ablation (GFMA) following following discontinuation of GLP-1 therapy. This will be performed by an experienced endoscopist specialized in bariatric endoscopy in a single endoscopic session.

Who Is Running the Clinical Trial?

Dr. Christopher McGowan

Lead Sponsor

Trials

2

Recruited

30+

Published Research Related to This Trial

In a study of 13 post-OAGB patients, the excluded stomach fundoplication (ESF) procedure significantly improved symptoms of gastroesophageal reflux, with heartburn scores dropping from an average of 22.7 to 1.8 (p < 0.05).

After ESF, 100% of patients reported satisfaction with their symptom improvement, and 11 out of 12 patients no longer needed proton pump inhibitors (PPIs), indicating the procedure's efficacy in managing refractory bile reflux.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic Fundoplication Using the Excluded Stomach as a Novel Management Option for Refractory Bile Reflux Following One Anastomosis Gastric Bypass (OAGB). Werapitiya, SB., Ruwanpura, SP., Coulson, TR.[2022]

Combining Silastic ring vertical gastroplasty with Nissen fundoplication in an animal model effectively protects against gastroesophageal reflux.

The combined procedures did not negatively impact pouch emptying, suggesting a safe approach for managing both morbid obesity and gastroesophageal reflux.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vertical Silastic Ring Gastroplasty with Nissen Fundoplication Prevents Reflux. Fisher, BL., Little, AG.[2019]

In a study of 35 patients undergoing surgical revision for gastrogastric fistula (GGF) after obesity surgery, those who had prior endoscopic closure attempts did not experience higher surgical complications compared to those who went directly to surgery.

The overall complication rates were 40.9% for the endoscopy group and 46.1% for the surgery-only group, indicating that prior endoscopic intervention is safe and does not negatively impact surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic management of gastrogastric fistulae does not increase complications at bariatric revision surgery. Flicker, MS., Lautz, DB., Thompson, CC.[2021]

Gastric fundus invagination (GFI) surgery resulted in lower fasting ghrelin levels compared to gastric plication (GP), suggesting a more effective mechanism for weight loss through hormonal regulation.

GFI demonstrated better durability, as all GFI rats maintained their fundus invagination, while three GP rats experienced unfurling of the plication, indicating that GFI may be a more reliable surgical option for long-term weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of gastric fundus invagination and gastric greater curvature plication for weight loss in a rat model of diet-induced obesity. Darido, E., Moore, JR.[2021]

Endoscopic repair of gastrogastric fistulas (GGFs) after Roux-en-Y gastric bypass is technically feasible and achieved a high initial closure rate of 95% in a study of 95 patients.

However, the durability of the closure is limited, with 65% of the fistulas reopening within an average of 177 days, and larger fistulas (over 20 mm) had a significantly lower chance of remaining closed compared to smaller ones (10 mm or less).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic repair of gastrogastric fistula after Roux-en-Y gastric bypass: a less-invasive approach. Fernandez-Esparrach, G., Lautz, DB., Thompson, CC.[2010]

Bariatric surgery is the most effective long-term treatment for obesity, significantly improving weight loss and reducing obesity-related health complications, especially in patients with a BMI over 40 or over 35 with related health issues.

While bariatric surgery can lead to decreased overall mortality, careful patient selection is crucial due to the potential for serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of obesity. Bult, MJ., van Dalen, T., Muller, AF.[2022]

Obesity is a significant risk factor for various gastrointestinal and hepatic diseases, including nonalcoholic fatty liver disease, gastroesophageal reflux disease, and several types of cancer, highlighting the need for awareness of these complications among healthcare providers.

Gastroenterologists play a crucial role in managing obesity-related diseases due to their expertise in nutrition and endoscopic interventions, making them key players in a multidisciplinary approach to treating obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal Complications of Obesity. Camilleri, M., Malhi, H., Acosta, A.[2022]

A study analyzing gastric mucosa samples from control subjects and patients with obesity and diabetes revealed significant changes in gene expression, with 1756 genes upregulated and 1053 downregulated in patients with obesity and diabetes compared to controls.

Key pathways affected include the PI3K-Akt and AGE-RAGE signaling pathways, which are crucial for metabolic processes, indicating that the stomach plays a significant role in the mechanisms underlying obesity and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Key pathway and gene alterations in the gastric mucosa associated with obesity and obesity-related diabetes. Wen, X., Qian, C., Zhang, Y., et al.[2020]

Gastric bypass surgery, although technically challenging and associated with a higher risk of complications, is an effective treatment for controlling gastroesophageal reflux in obese patients who have previously undergone antireflux surgery, with most patients experiencing complete symptom remission.

In a review of 121 patients, the average body mass index was 37.17 kg/m², and the surgery resulted in significant excess weight loss alongside improved reflux symptoms, highlighting its dual benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FUNDOPLICATION CONVERSION IN ROUX-EN-Y GASTRIC BYPASS FOR CONTROL OF OBESITY AND GASTROESOPHAGEAL REFLUX: SYSTEMATIC REVIEW. Mendes-Filho, AM., Godoy, ESN., Alhinho, HCAW., et al.[2022]

Citations

1. gastrojournal.org gastrojournal.org/article/S0016-5085(24)05349-6/abstract

Endoscopic Gastric Fundal Mucosal Ablation Induces ... We conducted a first-in-human study of GFMA to appraise its safety, feasibility, and the mechanistic underpinnings of appetite control.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06428617

Study Details | NCT06428617 | Fundus Ablation Registry ... The purpose of this study is to construct a multi-site, prospective registry to evaluate the clinical outcomes of patients who have undergone gastric fundus ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06428617/fundus-ablation-registry-gastric-fundus-mucosal-ablation-for-weight-loss?state=NC&city=Cary

Fundus Ablation Registry (Gastric Fundus Mucosal ... This is a multi-site, prospective registry of patients who have elected to undergo Gastric Fundus Mucosal Ablation (GFMA) at a True You Weight Loss site.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39154777/

Endoscopic Gastric Fundal Mucosal Ablation Induces ... Endoscopic Gastric Fundal Mucosal Ablation Induces Weight Loss in Adults With Obesity. Gastroenterology. 2024 Dec;167(7):1457-1459.

5. istanbulbariatriccenter.com istanbulbariatriccenter.com/gastric-fundus-mucosal-ablation-gfma-latest-news

Gastric Fundus Mucosal Ablation (GFMA) Latest News According to data presented in 2025 from the ABLATE I & II trials, the ESG+GFMA combination achieved an average total body weight loss of about ...

6. trialx.com trialx.com/clinical-trials/listings/296818/fundus-ablation-registry-gastric-fundus-mucosal-ablation-for-weight-loss/

Fundus Ablation Registry (Gastric Fundus Mucosal ... The purpose of this study is to construct a multi-site, prospective registry to evaluate the clinical outcomes of patients who have undergone ...

7. withpower.com withpower.com/trial/gastric-fundal-mucosal-ablation-for-obesity-5e1ad

Gastric Fundal Mucosal Ablation for Obesity - Clinical Trials The purpose of this study is to assess the effect of gastric fundal mucosal ablation (GFMA) on weight trajectory following discontinuation of once-weekly ...