We are evaluating an investigational procedure to determine whether it may help lower HbA1c in adults with Type 2 Diabetes. This is a same-day, non-surgical treatment for adults with Type 2 Diabetes.
If you're living with Type 2 Diabetes and looking for new ways to reach your health goals, the RESTORE-1 Clinical Research Study might be right for you.
Living with Type 2 Diabetes often means balancing multiple daily medications, making ongoing lifestyle changes, and, for some people, considering more invasive treatment options such as surgery.
There could be a new approach to managing Type 2 Diabetes; a same-day procedure to lower HbA1c.
The RESTORE-1 study is evaluating an investigational procedure that targets the small intestine to help the body naturally regulate blood sugar.
A specialized physician performs the procedure entirely through a flexible tube passed through the mouth to treat the small bowel. There are no surgical cuts and no permanent implants left behind.
The procedure uses standard, routine medical sedation so that you remain completely comfortable and asleep throughout.
Review the simple checklists below. If your current health matches these points, you may be an ideal candidate for this study.
Are an adult between 18 - 65 living with Type 2 Diabetes.
Have BMI 25 - 40 kg.
Take at least one type of diabetes medications.
Have had prior bariatric (gastric bypass or weight-loss) surgery.
Have severe, chronic stomach or intestinal diseases.
If you are ready to see if the RESTORE-1 study is for you, choose an option below to connect with our secure, IRB-approved screening portal.
To learn more about current research opportunities or see if you qualify, visit the ClinicalTrials.gov webpage
View the map below to see which clinical study site is nearest to you.
The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract. Use of the RFVA system for the PIMA procedure is investigational. The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established.
If you qualify and choose to Join:
All study-related medical evaluations, blood work, procedures, and follow-up care are provided at no cost to you.
Participants will be offered reasonable compensation for taking part in this study.
You will be closely monitored by a team of specialized diabetes doctors and research staff.
Your participation is 100% voluntary. You can change your mind and withdraw from the study at any time, for any reason.
Information you provide through this website will be used to assess your potential eligibility for the study and to contact you about possible participation. Your information will be handled in accordance with applicable privacy requirements and may be shared with authorized parties involved in study recruitment and screening.
Aqua Medical is a U.S.-based clinical-stage medical technology company advancing a minimally invasive, through-the-working-channel-of-the-scope technology for the treatment of type 2 diabetes. Using its proprietary radiofrequency vapor ablation (RFVA) system for the Proximal Intestinal Mucosal Ablation (PIMA) procedure, the company is evaluating a device-based approach intended to modify the proximal intestinal mucosa and potentially improve glycemic control and reduce reliance on diabetes medications.
The RFVA system is FDA-cleared for marketing for its indicated use in the gastrointestinal tract. Use of the RFVA system for the PIMA procedure is investigational. The safety and effectiveness of the RFVA system for the PIMA procedure have not yet been established.