The RESET System Pivotal Clinical Trial (Protocol Revision H)
NCT: NCT04101669 · RECRUITING
Brief Summary
A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study. A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (RESET):1 (Sham).
Frequently Asked Questions
What is The RESET System Pivotal Clinical Trial (Protocol Revision H)?
The RESET System Pivotal Clinical Trial (Protocol Revision H) is a clinical trial registered under NCT04101669. Current status: RECRUITING.
What is the status of NCT04101669?
The current status of NCT04101669 (The RESET System Pivotal Clinical Trial (Protocol Revision H)) is: RECRUITING.
When did The RESET System Pivotal Clinical Trial (Protocol Revision H) start?
The RESET System Pivotal Clinical Trial (Protocol Revision H) started on 2019-09-09.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.