Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-04 @ 11:51 PM
Study NCT ID:
NCT07231757
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The RADIANCE CED Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016503', 'term': 'Drug Delivery Systems'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-09-15', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment for Changes in Blood Pressure', 'timeFrame': 'November 2025 - December 2029'}], 'secondaryOutcomes': [{'measure': 'Occurrence of Adverse Cardiovascular and Cerebrovascular Event', 'timeFrame': 'November 2025 - December 2029'}, {'measure': 'Changes in Anti-Hypertensive Medication', 'timeFrame': 'November 2025 - December 2029'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hypertension', 'Cardiovascular Diseases', 'Vascular Diseases']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults aged ≥ 65 years with uncontrolled hypertension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Common Inclusion Criteria:\n\n* Adults aged ≥65 years with uncontrolled hypertension\n* Stable regimen of blood pressure-lowering medication\n\nCommon Exclusion Criteria:\n\n* Hypertension due to secondary causes\n* Prior renal denervation treatment\n* Pregnancy\n* End-stage renal disease, dialysis, or kidney transplant'}, 'identificationModule': {'nctId': 'NCT07231757', 'briefTitle': 'The RADIANCE CED Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'ReCor Medical, Inc.'}, 'officialTitle': 'The Recor Paradise System™ Hypertension Coverage With Evidence Development Study', 'orgStudyIdInfo': {'id': 'RADIANCE CED'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposure Group (uRDN + SOC)', 'description': 'A procedure or device code for the Paradise™ ultrasound renal denervation system (uRDN) and medication records indicating receipt of blood pressure-lowering medications.', 'interventionNames': ['Device: Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)']}, {'label': 'Comparator Group (SOC)', 'description': 'Medication records indicating receipt of blood pressure-lowering medications.'}], 'interventions': [{'name': 'Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)', 'type': 'DEVICE', 'otherNames': ['Paradise™ ultrasound renal denervation system'], 'description': 'A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.', 'armGroupLabels': ['Exposure Group (uRDN + SOC)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Helen Reeve-Stoffer, Ph.D', 'role': 'CONTACT', 'email': 'hreeve-stoffer@recormedical.com', 'phone': '650-542-7700'}, {'name': 'Elizabeth A Sheehan, MLIS, MA', 'role': 'CONTACT', 'email': 'liz.sheehan@recormedical.com', 'phone': '650-542-7700'}], 'overallOfficials': [{'name': 'Megan Coylewright, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Essentia Health'}, {'name': 'Amir Kaki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ascension St. John Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data (IPD) available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ReCor Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}