Ignite Creation Date:
2024-05-06 @ 1:42 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04101669
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2019-09-20
Brief Title:
RESET System Pivotal Trial Rev F
Sponsor:
GI Dynamics
Organization:
GI Dynamics
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP-1
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 RESET1 Sham
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 RESET1 Sham
Detailed Description:
The objective of this study is to evaluate the safety and effectiveness of the RESET System when used with moderate intensity lifestyle and dietary counseling and medical management in patients with baseline HbA1c 75 and 10 and BMI 30 kgm2 and 50kgm2 whose diabetes medications consist of at least dual therapy for 3 months yet have not achieved adequate HbA1c control 7
Specific objectives of this study are
1 To determine if the RESET System significantly improves glycemic control
2 To determine that the RESET System can be safely used to improve glycemic control
Specific objectives of this study are
1 To determine if the RESET System significantly improves glycemic control
2 To determine that the RESET System can be safely used to improve glycemic control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None