HypertensionNCT07231757
The RADIANCE CED Study
An observational study of Hypertension and Cardiovascular Diseases, run by ReCor Medical, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Diseases, Vascular Diseases
- What is being tested?
- Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2025to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Adults aged ≥ 65 years with uncontrolled hypertension
Common Inclusion Criteria:
- Adults aged ≥65 years with uncontrolled hypertension
- Stable regimen of blood pressure-lowering medication
Common Exclusion Criteria:
- Hypertension due to secondary causes
- Prior renal denervation treatment
- Pregnancy
- End-stage renal disease, dialysis, or kidney transplant
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Michelle Butcher, 586-202-0376, mbutche1@hfhs.org
Herbert Aronow, MD
- Recruiting
Henry Ford St. John Hospital
Detroit, Michigan, 48236
Amir Kaki, MD
About this study
Official title: The Recor Paradise System™ Hypertension Coverage With Evidence Development Study
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
- Hypertension, Cardiovascular Diseases, Vascular Diseases
- Being tested
- Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)Device
Also called Paradise™ ultrasound renal denervation system
A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System) | |
| Comparator Group (SOC) | Medication records indicating receipt of blood pressure-lowering medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment for Changes in Blood Pressure
Measured: November 2025 - December 2029
Secondary outcomes (2)
Occurrence of Adverse Cardiovascular and Cerebrovascular Event
Measured: November 2025 - December 2029
Changes in Anti-Hypertensive Medication
Measured: November 2025 - December 2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start21 Nov 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReCor Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Megan Coylewright, MD, Principal investigator, Essentia HealthAmir Kaki, MD, Principal investigator, Ascension St. John Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231757
- Sponsor's protocol ID
- RADIANCE CED
- Status last verified
- Jul 2026
- First submitted
- 15 Sep 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Recor Paradise System™ Hypertension Coverage With Evidence Development Study
- ClinicalTrials.gov ID
- NCT07231757
- Acronym / sponsor ID
- RADIANCE CED
- Conditions
- Hypertension, Cardiovascular Diseases, Vascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- ReCor Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure Group (uRDN + SOC) | – | Device: Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)A procedure or device code for the Paradise™ ultrasound renal denervation system (uRDN) and medication records indicating receipt of blood pressure-lowering medications. |
| Comparator Group (SOC) | – | –Medication records indicating receipt of blood pressure-lowering medications. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Adults aged ≥ 65 years with uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)Also: Paradise™ ultrasound renal denervation systemA catheter-based system that delivers ultrasound energy to the renal sympathetic nerves. | Device | Exposure Group (uRDN + SOC) |
Primary outcome
Assessment for Changes in Blood Pressure
Time frame: November 2025 - December 2029
2 secondary outcomes
Occurrence of Adverse Cardiovascular and Cerebrovascular Event
Time frame: November 2025 - December 2029
Changes in Anti-Hypertensive Medication
Time frame: November 2025 - December 2029
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Coylewright, MD principal investigator
Essentia Health
Amir Kaki, MD principal investigator
Ascension St. John Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Cardiovascular Diseases, run by ReCor Medical, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Reeve-Stoffer, Ph.D (650-542-7700, hreeve-stoffer@recormedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment for Changes in Blood Pressure (time frame: November 2025 - December 2029). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.