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

Trial Summary

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 data supports the effectiveness of the treatment Gastric Mucosal Ablation for Obesity?

Research using pigs, which have similar stomachs to humans, shows that Gastric Mucosal Devitalization (GMD) can safely and effectively reduce body weight and fat. This suggests that the treatment might help with weight loss in humans too. ^{1 2 3 4 5}

Is Gastric Mucosal Ablation safe for humans?

Research on Gastric Mucosal Devitalization (GMD) in pigs suggests it is safe, as it was tested for weight loss without significant harm. A study using human stomach specimens showed that the procedure can be done without damaging deeper stomach layers, indicating potential safety in humans. ^{1 2 3 5 6}

How does the treatment Gastric Mucosal Ablation (GMA) for obesity differ from other treatments?

Gastric Mucosal Ablation (GMA) is unique because it involves endoscopically devitalizing (destroying) the stomach lining without reducing stomach size, using a technique called argon plasma coagulation (APC). This approach targets the stomach's mucosa, which plays a role in metabolism, offering a novel way to achieve weight loss compared to traditional surgeries that physically alter the stomach's size. ^{1 2 5 7 8}

What is the purpose of this trial?

The purpose of this study is to evaluate the feasibility, safety, and tolerability of endoscopic selective gastric mucosal ablation (GMA) using argon plasma coagulation after sleeve gastrectomy. In this study, GMA will be performed on patients who have experienced weight regain following an initial successful response to sleeve gastrectomy.

Research Team

Christopher McGowan, MD

Principal Investigator

True You Weight Loss

Eligibility Criteria

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

Should be able to comply with study requirements, understand, and sign the Informed Consent Form

Must express willingness to comply with substantial lifelong dietary restrictions required by the procedure

I had sleeve gastrectomy surgery over three years ago.

Exclusion Criteria

I have a condition affecting my digestive system.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Gastric Mucosal Devitalization (GMD): Using the Porcine Model to Develop a Novel Endoscopic Bariatric Approach. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Gastric mucosal devitalization is safe and effective in reducing body weight and visceral adiposity in a porcine model. [2018]

3. Australia pubmed.ncbi.nlm.nih.gov

Clinical outcomes of anti-reflux mucosal ablation for gastroesophageal reflux disease: An international bi-institutional study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Antireflux mucosal intervention (ARMI) procedures for refractory gastroesophageal reflux disease: a systematic review and meta-analysis. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Gastric mucosal devitalization (GMD): translation to a novel endoscopic metabolic therapy. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Cytosponge-TFF3 Testing can Detect Precancerous Mucosal Changes of the Stomach. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. Russia (Federation) 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]. [2016]