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RADIANCE Continued Access Protocol

NCT05017935 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-06-17

No results posted yet for this study

Summary

RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.

Conditions

Interventions

DEVICE

Renal Denervation

Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)

Sponsors & Collaborators

  • ReCor Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Naomi Fisher, MD · Brigham and Women's Hospital/Harvard Medical School

  • Ajay Kirtane, MD, SM · Columbia University Medical Center/NYPH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-04
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05017935 on ClinicalTrials.gov