Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2025-11-21
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Exposure Group (uRDN + SOC)
A procedure or device code for the Paradise™ ultrasound renal denervation system (uRDN) and medication records indicating receipt of blood pressure-lowering medications.
Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.
Comparator Group (SOC)
Medication records indicating receipt of blood pressure-lowering medications.
No interventions assigned to this group
Interventions
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Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable regimen of blood pressure-lowering medication
Exclusion Criteria
* Prior renal denervation treatment
* Pregnancy
* End-stage renal disease, dialysis, or kidney transplant
65 Years
ALL
No
Sponsors
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ReCor Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Megan Coylewright, MD
Role: PRINCIPAL_INVESTIGATOR
Essentia Health
Amir Kaki, MD
Role: PRINCIPAL_INVESTIGATOR
Ascension St. John Hospital
Locations
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Henry Ford St. John Hospital
Detroit, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Amir Kaki, MD
Role: primary
Other Identifiers
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RADIANCE CED
Identifier Type: -
Identifier Source: org_study_id
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