Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT04917393
Status:
UNKNOWN
Last Update Posted:
2022-06-21
First Post:
2021-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-Organ Denervation With the iRF System to RedUce Sympathetic Drive
Sponsor:
Metavention
Organization:
Study Overview
Official Title:
Multi-Organ Denervation to RedUce Sympathetic Drive, Multi-Center, Prospective Feasibility Study - The MODUS ON MED Study
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
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:
MODUS
Brief Summary:
The objective of the study is to evaluate the safety of multi-organ denervation using the Integrated Radio Frequency (iRF) Denervation System. and to understand any potential improvement in hypertension and glycemic control.
Detailed Description:
This study is a prospective, single-arm, multi-center, sham contollred trial to evaluate the initial safety and performance of multi-organ denervation for the treatment of hypertension and type 2 diabetes.
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?: