RESET® is intended for patients who do not have adequate control of their type 2 diabetes and obesity through their current medication and lifestyle.
RESET® is intended for patients who do not have adequate control of their type 2 diabetes and obesity through their current medication and lifestyle.
RESET® is a minimally-invasive medical device that is endoscopically implanted temporarily in the small intestine directly below the stomach. It has been shown to reduce HbA1c, BMI, weight, and other health-related metrics through previous clinical studies that were preformed outside of the US.
For a medical device to become commercially available in the US, it must go through extensive clinical research to support that it is safe and effective to the Food and Drug Administration (FDA) via clinical trial data.
The STEP-1 Trial is currently enrolling patients at 6 clinical study sites.
You may be a candidate if these apply to you.
Morphic Medical is currently enrolling patients for its STEP-1 clinical study of RESET® in the United States. Learn more if you or someone you know are interested in participating in the study and would like to see if you qualify to join.
RESET® is limited by Federal (US) Law to investigational use only and is not for sale in any geography.
Brigham & Women’s Hospital
Boston, MA
University of Miami Hospital
Miami, FL
Michigan Medicine
Ann Arbor, MI
Baylor College of Medicine
Houston, TX
Thomas Jefferson University Hospital
Philadelphia, PA
MedStar Health
Washington D.C. & Olney, MD
1. Why should I participate in this study?
Participants in the STEP-1 trial may obtain significant health benefits, as well as aid in the possibility of bringing a much-needed medical device to the Unites States market for other people unable to control their type 2 diabetes with the current care they are receiving.
2. How long will I be in the study?
The study duration is 24 months.
3. What are the requirements of the study?
During the study you will be required make regular visits to the study doctors, and to measure your blood sugars and temperature daily. Your study doctor will order blood tests, liver scans and other tests regularly throughout the trial. Additionally, you will receive lifestyle guidance regularly from a registered dietician.
4. Will it cost me anything to be in the study?
No.
5. Will I be compensated to be in the study?
Participants are not paid to be part of the study but will be receiving, at no charge, regular medical care and lifestyle counseling throughout the study. Participants will receive compensation for travel expenses.
Additional information about this trial can be found HERE at ClinicalTrials.gov.
