Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT02827032
Status:
RECRUITING
Last Update Posted:
2023-10-06
First Post:
2016-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlling and Lowering Blood Pressure With the MobiusHD™
Sponsor:
Vascular Dynamics, Inc.
Organization:
Study Overview
Official Title:
Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers
Status:
RECRUITING
Status Verified Date:
2023-10
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:
CALM-DIEM
Brief Summary:
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.
Detailed Description:
The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.
Study Oversight
Has Oversight DMC:
True
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?: