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

  • STATUS
    Recruiting
  • participants needed
    10
Send
Updated on 19 February 2024

Summary

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.

Description

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.

FAQ


Details
Condition hypertension
Age 18years - 90years
Clinical Study IdentifierTX6058
Last Modified on19 February 2024

Eligibility

How to participate?

Step 1 Connect with a study center
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

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.