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The "Global Paradise System" Registry

Study acronym: GPSRegistry
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study sites: 35 to 55
    • Study description expanded, about 143 words
    v8
  2. Study sites: 2 to 35v7
  3. Study sites: 1 to 2v6
  4. Start date changed from estimate of Dec 22, 2021 to Jan 13, 2022v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 31, 2021 to Dec 22, 2021
    • Study sites: 0 to 1
    v4
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  1. Interventions: The Paradise® Ultrasound Renal Denervation System (Device) to The Paradise Ultrasound Renal Denervation System (Device)
    • Eligibility criteria revised
    • Study title revised
    v3
  2. Primary endpoints revised (23)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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a standardized quality of life questionnaire. The objective of the GPS Registry is to document the long-term safety and effectiveness of the commercially available Paradise Ultrasound Renal Denervation System when used per its labelling in patients deemed to be candidates for RDN as per physician's assessment.
Trial Details
NCT Number NCT05027685
Lead Sponsor ReCor Medical, Inc.
Conditions
(from sponsor)		 Hypertension
Related terms Hypertension
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov