The RADIANCE-HTN Clinical Study-TRIO COHORT: A Study of the ReCor Medical PARADISE® System in Clinical Hypertension

The RADIANCE-HTN Clinical Study-TRIO COHORT: A Study of the ReCor Medical PARADISE® System in Clinical Hypertension
Recruiting
18 years - 90 years
All
Phase N/A
10 participants needed

Brief description of study

High blood pressure is also known as “hypertension.” The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in patients who are known to have hypertension. Renal denervation utilizing the Paradise system uses therapeutically heated ultrasound energy to disrupt nerve activity by either disabling or destroying the nerves that provide signals to the kidney and may lower blood pressure.

Detailed description of study

People with high blood pressure may be on blood pressure lowering medications or they may not be on any medication. There are two groups in the study – the SOLO Cohort and the TRIO Cohort. The results of this study may be used to help the Food and Drug Administration (FDA) determine if the device should be approved in the USA. The SOLO Cohort has completed enrollment and preliminary results are available. The TRIO Cohort is still enrolling patients. You are being considered for enrollment in the TRIO cohort The Paradise System is a medical device made by a company called ReCor Medical Inc., based in Palo Alto, California in the USA. The device and the treatment delivered by the device, which is known as renal denervation, are investigational in the United States because they haven’t been approved by the FDA.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: hypertension
  • Age: 18 years - 90 years
  • Gender: All


Updated on 19 Feb 2024. Study ID: 831736

Find a site

Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact
Race
Ethnicity
Other language

Message For Non Enrolling By Invitation Trial

Select a study center that’s convenient for you, and get in touch with the study team.