Trials / Recruiting
RecruitingNCT07231757
The RADIANCE CED Study
The Recor Paradise System™ Hypertension Coverage With Evidence Development Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- ReCor Medical, Inc. · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
The RADIANCE CED study is a prospective observational study designed to evaluate the long-term effectiveness of ultrasound renal denervation in lowering blood pressure among patients with uncontrolled hypertension. Data will be collected from electronic health records (EHRs) of Medicare-eligible patients to support generalizability of outcomes to the broader Medicare population. Individual hospital enrollment is not required for this study and IRB exemption has been received by sponsor.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System) | A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves. |
Timeline
- Start date
- 2025-11-21
- Primary completion
- 2029-12-31
- Completion
- 2031-12-31
- First posted
- 2025-11-17
- Last updated
- 2026-01-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07231757. Inclusion in this directory is not an endorsement.