Gastric Mucosal Ablation for Obesity

(REVAMP Trial)

Overseen By Christopher McGowan, MD, MSCR

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Christopher McGowan

Must not be taking: Insulin, Anticoagulants, GLP-1 agonists, others

Disqualifiers: Diabetes, Autoimmune disease, Cardiovascular, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Gastric Mucosal Ablation (GMA) to determine its effectiveness for individuals who have regained weight after a sleeve gastrectomy. The study aims to assess whether GMA is safe, well-tolerated, and effective for weight management. It is suitable for individuals who had a sleeve gastrectomy at least three years ago, have regained at least 25% of the weight originally lost, and have a BMI of 30 or higher. Participants must avoid using weight loss medications during the trial. As an unphased trial, this study provides a unique opportunity to explore a new treatment option for weight management.

Will I have to stop taking my current medications?

The trial requires participants to stop using weight loss medications and supplements during the study. If you are taking any of these, you will need to stop them to participate.

What prior data suggests that this method is safe for patients with weight regain after sleeve gastrectomy?

Research has shown that gastric mucosal ablation (GMA) is generally safe and effective. Studies indicate that this procedure is simple to perform and does not lead to surgical complications. In one animal study, a similar procedure proved safe and helped reduce body weight and belly fat. Another study in humans also supported its safety and suggested it might help control appetite. While more research is needed, these findings suggest that GMA is well-tolerated and could be a promising option for managing weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Gastric Mucosal Ablation (GMA) is unique because it offers a novel approach to weight loss by targeting the stomach lining. Unlike traditional surgical options like gastric bypass or sleeve gastrectomy, GMA is performed endoscopically, meaning it's less invasive and potentially involves a quicker recovery time. Researchers are excited about GMA because it could enhance the effects of existing procedures, like sleeve gastrectomy, by further reducing hunger and calorie absorption, offering a promising new tool in the fight against obesity.

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

Research has shown that gastric mucosal ablation (GMA), which participants in this trial will undergo following sleeve gastrectomy, might help maintain weight loss after the initial surgery. One study found that 57.1% of patients reached their weight loss goals two years after undergoing GMA. This procedure uses argon plasma coagulation to treat the stomach lining, potentially reducing hunger. Early results suggest that GMA is safe and could effectively prevent weight regain. Overall, it appears promising for those facing obesity-related issues after their initial surgery. ^{1 3 4 5 6}

Who Is on the Research Team?

Christopher McGowan, MD

Principal Investigator

True You Weight Loss

Are You a Good Fit for This Trial?

This trial is for individuals who have regained weight after initially losing it following a sleeve gastrectomy surgery. It's not specified, but typically participants should be adults in stable health with no conditions that could interfere with the study.

Inclusion Criteria

I am between 22 and 60 years old.

I have tried and failed to lose weight through diet and exercise.

Must agree not to donate blood during the study

Exclusion Criteria

I have had diabetic ketoacidosis or a severe diabetic coma before.

I have an autoimmune condition, but it's only in my thyroid.

I have a condition affecting my digestive system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic Gastric Mucosal Ablation (GMA) following sleeve gastrectomy in a single endoscopic session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and metabolic improvements after the GMA procedure

12 months

Monthly visits for the first 4 months, then every 2 months

What Are the Treatments Tested in This Trial?

Interventions

• Gastric Mucosal Ablation (GMA)

Trial Overview The trial is testing Gastric Mucosal Ablation (GMA) using argon plasma coagulation on patients post-sleeve gastrectomy to see if it's safe and can help manage weight regain.

How Is the Trial Designed?

Group I: Gastric Mucosal Ablation (GMA) following sleeve gastrectomy Experimental Treatment 1 Intervention

Subjects will undergo endoscopic Gastric Mucosal Ablation (GMA) following sleeve gastrectomy. This will be performed by an experienced endoscopist specialized in bariatric endoscopy in a single endoscopic session.

Gastric Mucosal Ablation (GMA) is already approved in United States, European Union for the following indications:

Approved in United States as Gastric Mucosal Ablation for:

• Weight regain after sleeve gastrectomy

Approved in European Union as Gastric Mucosal Ablation for:

• Weight regain after sleeve gastrectomy
• Type 2 diabetes management

Who Is Running the Clinical Trial?

Dr. Christopher McGowan

Lead Sponsor

Trials

2

Recruited

30+

Published Research Related to This Trial

The pooled clinical success rate for antireflux mucosal interventions (ARMI) in treating refractory gastroesophageal reflux disease (GERD) was 73.8%, with ARMA showing the highest success rate at 86.7%.

While all three procedures (ARMS, ARMA, ARBL) were effective, ARMA and ARBL had fewer adverse events compared to ARMS, which had a 2.2% perforation rate and 10% dysphagia requiring further treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antireflux mucosal intervention (ARMI) procedures for refractory gastroesophageal reflux disease: a systematic review and meta-analysis. Yeh, JH., Lee, CT., Hsu, MH., et al.[2022]

In a study of 131 patients with severe obesity, it was found that their gastric mucosa oxygenation levels were significantly lower than those of healthy individuals, indicating compromised tissue health before surgery.

Post-surgery, the oxygenation levels improved significantly due to changes in diet, reduced food intake, and weight loss, demonstrating the effectiveness of the 'small stomach' operation without causing blood supply issues at the surgical site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Changes in the degree of oxygenation of gastric mucosa before and after the operation of creating a small stomach in patients with the extreme degree of alimentary-constitutional obesity]. Kashevarov, SB., Kuzin, NM., Zavodnov, VIa., et al.[2016]

The study established optimal ablation parameters for gastric mucosal devitalization (GMD) using argon plasma coagulation, identifying 120 W as effective for selective mucosal ablation in pigs.

In a trial with 8 pigs, those undergoing GMD showed significantly lower relative body weight increase and reduced body fat mass after 1 month compared to the sham group, suggesting GMD may be a promising endoscopic bariatric therapy for weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric Mucosal Devitalization (GMD): Using the Porcine Model to Develop a Novel Endoscopic Bariatric Approach. Itani, MI., Oberbach, A., Salimian, KJ., et al.[2022]

Anti-reflux mucosal ablation (ARMA) is a promising endoscopic treatment for gastroesophageal reflux disease (GERD), showing clinical success rates of 60% at 2-6 months and 70% at 1 year post-procedure among 68 patients studied.

The procedure significantly improved patients' quality of life and reduced acid exposure time from 5.3% to 0.7%, with a low incidence of complications, indicating that ARMA is both effective and safe for treating GERD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of anti-reflux mucosal ablation for gastroesophageal reflux disease: An international bi-institutional study. Shimamura, Y., Inoue, H., Tanabe, M., et al.[2023]

Gastric intestinal metaplasia (GIM) and gastric atrophy (GA) are significant risk factors for gastric cancer, necessitating endoscopic surveillance, especially in the proximal stomach.

Current endoscopic screening methods are not cost-effective in regions with low to moderate gastric cancer incidence, highlighting the need for noninvasive detection methods for GIM and GA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytosponge-TFF3 Testing can Detect Precancerous Mucosal Changes of the Stomach. Hadjinicolaou, AV., Azizi, AA., O'Donovan, M., et al.[2022]

Gastric mucosal devitalization (GMD) in a porcine model led to a significant relative weight loss of 36% compared to the sham group after 8 weeks, demonstrating its efficacy as a metabolic intervention.

GMD also improved visceral adiposity and reduced serum ghrelin levels without causing ulceration or significant scarring, indicating a safe approach with potential benefits beyond weight loss alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric mucosal devitalization is safe and effective in reducing body weight and visceral adiposity in a porcine model. Kumbhari, V., Lehmann, S., Schlichting, N., et al.[2018]

Using argon plasma coagulation (APC) for gastric mucosal devitalization (GMD) can achieve significant mucosal thermal injury, especially when targeting brown tissue color, which resulted in 99.6% injury in a study of six patients.

The study found that while brown tissue color led to the highest mucosal injury, a golden color also provided sufficient injury with minimal submucosal damage, indicating that GMD can be performed safely without harming deeper muscle layers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric mucosal devitalization (GMD): translation to a novel endoscopic metabolic therapy. Fayad, L., Oberbach, A., Schweitzer, M., et al.[2020]

In a study of 810 patients undergoing gastric bypass surgery, the incidence of gastro-gastric fistulas was significantly lower in patients who had their stomachs transected and a segment of jejunum interposed (0%) compared to those with stapled continuity (49%).

The use of absorbable sutures in hand-sewn anastomosis was associated with a reduced incidence of marginal ulceration, with rates dropping to 0% when both layers of the anastomosis were absorbable, suggesting that surgical technique and materials play a crucial role in postoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastro-gastric fistulas and marginal ulcers in gastric bypass procedures for weight reduction. Capella, JF., Capella, RF.[2007]

Citations

1. giejournal.org giejournal.org/article/S0016-5107(25)00312-8/fulltext

ENDOSCOPIC GASTRIC MUCOSAL ABLATION FOR ... The majority of patients presented with one or more comorbidities associated with obesity. At 2 years of post-EGMA, 4/7 (57.1%) patients achieved complete ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06671119

REvision of VSG with Ablation of the Mucosa Procedure The purpose of this study is to evaluate the feasibility, safety, and tolerability of endoscopic selective gastric mucosal ablation (GMA) using argon plasma ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6877422/

Gastric mucosal devitalization (GMD): translation to a novel ... However, comparative studies have shown superior weight loss outcomes with SG as compared to ESG . The explanation for this difference may lie in the ...

4. mayo.edu mayo.edu/research/clinical-trials/cls-20542401

Early Feasibility of Endoscopic Gastric Mucosal Ablation ... The purpose of this study is to assess the feasibility of ablation of up to 70% of the gastric mucosa using HybridAPC to induce weight loss.

5. 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.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05587491

HybridAPC for Gastric Mucosal Ablation in Obese Patients. Gastric mucosal devitalization is safe and effective in reducing body weight and visceral adiposity in a porcine model. Gastrointest Endosc. 2018 Jul;88(1): ...