Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2026-02-20 @ 11:25 AM
Study NCT ID:
NCT05631561
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2022-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endovascular Denervation for the Treatment of Type 2 Diabetes Mellitus
Sponsor:
Shanghai Golden Leaf MedTec Co. Ltd
Organization:
Study Overview
Official Title:
Endovascular Denervation for the Treatment of Type 2 Diabetes Mellitus - a Feasible Clinical Trial Protocol
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
This is a prospective, multicenter, single group feasibility clinical trial to evaluate the safety and efficacy of Endovascular denervation for the treatment of type 2 diabetes mellitus (T2DM) using the Endovascular denervation system (Generator and Catheter).
Detailed Description:
This is a prospective, multicenter, single group feasibility clinical trial. Patients with T2DM with poor glycemic control, glycated hemoglobin A1c (Hba1c) between 7.5% and 10.5% treatment with at least one to three oral antidiabetic drugs and/or insulin on the basis of metformin. All eligible patients will accept EDN treatment and were evaluated at 7, 30, 60, 90, 180, 365, 730 days post procedure. The primary safety endpoint is the number of composite major adverse events (MAE) \* related to the study device and/or the denervation procedure during procedure and within 30 days after the procedure, the primary efficacy is Hba1c changes from baseline to 6 months post procedure.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: