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Baroloop Multicenter Trial (Baroloop MCT)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 2 to 4v4
  2. Study sites: 1 to 2v3
  3. Interventions: Baroloop system (Device) to baroloop system (Device)
    • Study title expanded, about 2 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06518915
Lead Sponsor neuroloop GmbH
Collaborators: Avania
Conditions
(from sponsor)		 Hypertension, Resistant to Conventional Therapy
Related terms Hypertension Resistant to Conventional Therapy
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov