Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518915
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Baroloop Multicenter Trial Baroloop MCT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Baroloop MCT - A Multicenter Trial of Safety and Performance of Baroloop
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn weather the baroloop system is safe and works to treat hypertension in adults that do not respond sufficiently to medication The main questions it aims to answer are
Is the baroloop device associated with any major medical problems including death
Does the baroloop lower the blood pressure of study participants
Participants will be implanted with the baroloop device Afterwards they will visit the clinic after 14 days 3 months 6 months 12 months 18 months and 24 months for adjustment of the device settings andor other study related assessments Participants will also be asked to answer questions regarding their quality of life
Is the baroloop device associated with any major medical problems including death
Does the baroloop lower the blood pressure of study participants
Participants will be implanted with the baroloop device Afterwards they will visit the clinic after 14 days 3 months 6 months 12 months 18 months and 24 months for adjustment of the device settings andor other study related assessments Participants will also be asked to answer questions regarding their quality of life
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None