Trials / Recruiting
RecruitingNCT06518915
Baroloop Multicenter Trial (Baroloop MCT)
Baroloop MCT - A Multicenter Trial of Safety and Performance of Baroloop
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- neuroloop GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 and/or other study related assessments. Participants will also be asked to answer questions regarding their quality of life.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | baroloop system | Participants will have the baroloop device implanted for selective stimulation of the vagus nerve. |
Timeline
- Start date
- 2024-05-22
- Primary completion
- 2029-05-01
- Completion
- 2031-12-01
- First posted
- 2024-07-25
- Last updated
- 2025-04-17
Locations
4 sites across 2 countries: Germany, Netherlands
Source: ClinicalTrials.gov record NCT06518915. Inclusion in this directory is not an endorsement.