Restore-1 Trial: New Steam-Based Endoscopic Procedure for Type 2 Diabetes
The HonorHealth Research Institute is preparing to launch the Restore-1 clinical trial, investigating a novel, minimally invasive endoscopic technique that uses steam to ablate the duodenal mucosa in patients with type 2 diabetes. The goal is to regenerate the lining and potentially restore natural blood sugar control.
"This technique is designed to prevent patients from advancing to insulin-dependent diabetes."
— Dr. James Swain, principal investigator
Trial Overview & Sponsorship
The study is sponsored by Aqua Medical, a medical device manufacturer based in Santa Ana, California. Participation is free—the sponsor covers all costs for tests, procedures, and clinical visits.
Study duration: Up to 8 months, with follow-up appointments at 1 week, 3 months, and 6 months, plus phone consultations on days 2 and 14.
Who Can Participate?
- Type 2 diabetes diagnosed for at least one year, inadequately controlled with current medications, diet, and exercise.
- Age: 22–65 years.
- Body mass index (BMI): 24–40 kg/m².
- Not currently taking insulin.
- HbA1c: 7.5–10%.
Why Steam?
James Swain, M.D., medical director of the Research Institute's Bariatrics/GI Research Division and principal investigator, explained that steam may provide more complete treatment because it can reach small areas, potentially making the therapy more thorough, effective, and easier to perform.
Background Context
Similar duodenal mucosal resurfacing technologies have previously been used to treat type 2 diabetes and promote weight loss. The Restore-1 trial is specifically designed to evaluate this steam-based approach and its potential to halt disease progression.