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True You Weight Loss to initiate two clinical trials assessing gastric fundal mucosal ablation

True You Weight Loss, a dedicated endobariatric weight loss center, has announced two new FDA-authorised clinical trials aimed at providing innovative, non-surgical solutions for long-term weight loss without the need for GLP-1 medications.



Earlier this year, True You Weight Loss introduced a weight loss procedure called gastric fundal mucosal ablation (GFMA). GMFA is a non-surgical technique in which a gastroenterologist uses an endoscope to ablate (thermally treat) the inner lining of the gastric fundus, the top portion of the stomach. This procedure reduces levels of the hunger hormone ghrelin, resulting in decreased appetite and rapid weight loss. True You Weight Loss has now performed nearly 300 GFMA cases with exceptional safety and promising outcomes.



The Mucosal AblatIoN Therapy After Incretins (MAINTAIN) trial is the first-ever study to evaluate the impact of GFMA on weight maintenance after discontinuing GLP-1 medications such as Wegovy/Ozempic (semaglutide) or Mounjaro/Zepbound (tirzepatide). The study aims to determine whether GFMA can prevent or minimise weight regain in adults transitioning off these medications, offering a potential solution for patients who cannot or prefer not to continue lifelong GLP-1 therapy due to cost, side effects, supply issues, or medication fatigue.


Christopher McGowan

“This is an important study coming at a critical time, said Dr Christopher McGowan, founder of True You Weight Loss and lead investigator of the study. “While GLP-1 medications are highly effective during use, they do not induce permanent changes in the body. Once the medication is discontinued, hunger and weight often return quickly. With GFMA, we aim to target the body’s strongest hunger pathway - the ghrelin hormone - offering patients long-term appetite control and sustainable weight management. Our GFMA patients report an altered relationship with food - including reduced cravings and food noise - without the side effects and ongoing cost of weight loss medications.”


The REvision of VSG with Ablation of the Mucosa Procedure (REVAMP) trial is the first study to evaluate whether the mucosal ablation procedure can promote weight loss in patients who have regained weight after vertical sleeve gastrectomy (VSG). This single-session, non-surgical ablation procedure will treat patients who have regained at least 25 percent of their initial weight loss following VSG.


“Obesity is a chronic, lifelong condition, and patients deserve lasting treatments,” said added McGowan. “Many patients who undergo bariatric surgery experience weight recurrence over time. REVAMP will explore whether mucosal ablation can help these patients lose weight again without the need for additional surgeries or medications. These trials represent a major step forward in developing non-surgical, effective weight loss solutions.”


Both MAINTAIN and REVAMP will run for one year and are actively enrolling participants.

 

 

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