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RADIANCE Continued Access Protocol

Study acronym: RADIANCE CAP
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv28
  2. Study sites: 37 to 40v27
  3. Re-verified, no change to tracked fieldsv26
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 37 of 37 sites
    v25
  5. Study sites: 27 to 37v24
Show 22 earlier versionsHide 22 earlier versions
  1. Study sites: 26 to 27v23
  2. Study sites: 21 to 26v22
  3. Study sites: 19 to 21v21
  4. Study sites: 14 to 19v20
  5. Study sites: 12 to 14v19
  6. Site contacts updated at 3 of 12 sitesv18
  7. Site contacts updated at 1 of 12 sitesv17
  8. Site contacts updated at 1 of 12 sitesv16
  9. Site contacts updated at 1 of 12 sitesv15
  10. Study sites: 11 to 12v14
  11. Study sites: 10 to 11v13
  12. Study sites: 7 to 10v12
  13. Enrollment target: 150 to 300
    • Eligibility criteria shortened, about 8 words
    • Study title shortened, about 1 word
    v11
  14. Study sites: 5 to 7v10
  15. Study sites: 6 to 5v9
  16. Site details revised at 2 of 6 sitesv8
  17. Site details revised at 1 of 6 sitesv7
  18. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 6
    • Start date changed from estimate of Apr 30, 2022 to May 4, 2022
    v6
  19. Study sites: 0 to 1v5
  20. Re-verified, no change to tracked fieldsv4
  21. Start date: Mar 1, 2022 to Apr 30, 2022v3
  22. Start date: Dec 1, 2021 to Mar 1, 2022v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
ReCor Medical, Inc.
6 trials monitored
See 1 trial at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
Hypertension
1,925 trials monitored
See 99 trials at risk
RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.
Trial Details
NCT Number NCT05017935
Lead Sponsor ReCor Medical, Inc.
Conditions
(from sponsor)		 Hypertension, Hypertension, Resistant to Conventional Therapy, Vascular Diseases, Cardiovascular Diseases
Related terms Cardiovascular Diseases, Essential Hypertension, Hypertension, Hypertension Resistant to Conventional Therapy, Vascular Diseases
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov