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Global Paradise System US Post Approval Study

Study acronym: US GPS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 12, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial sites expanded: 39 → 43 locationsv22
  2. Study sites: 38 to 39v21
  3. Trial sites expanded: 34 → 38 locationsv20
  4. Study sites: 32 to 34v19
  5. Study sites: 26 to 32v18
Show 16 earlier versionsHide 16 earlier versions
  1. Re-verified, no change to tracked fieldsv17
  2. Study sites: 25 to 26v16
  3. Study sites: 24 to 25v15
  4. Study sites: 23 to 24v14
  5. Study sites: 22 to 23v13
  6. Study sites: 15 to 22v12
  7. Site details revised at 1 of 15 sitesv11
  8. Study sites: 11 to 15v10
  9. Study sites: 10 to 11v9
  10. Study sites: 9 to 10v8
  11. Study sites: 7 to 9v7
  12. Study sites: 5 to 7v6
  13. Site details revised at 2 of 5 sitesv5
  14. Study sites: 3 to 5v4
  15. Study sites: 1 to 3v3
  16. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2024 to Jun 28, 2024
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure.
Trial Details
NCT Number NCT06297291
Lead Sponsor ReCor Medical, Inc.
Conditions
(from sponsor)		 Hypertension, Cardiovascular Diseases, Vascular Diseases
Related terms Cardiovascular Diseases, Essential Hypertension, Hypertension, Vascular Diseases
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov