Trials / Recruiting
RecruitingNCT05027685
The "Global Paradise System" Registry
The "Global Paradise® System" Registry
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,000 (estimated)
- Sponsor
- ReCor Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a standardized quality of life questionnaire. The objective of the GPS Registry is to document the long-term safety and effectiveness of the commercially available Paradise Ultrasound Renal Denervation System when used per its labelling in patients deemed to be candidates for RDN as per physician's assessment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | The Paradise Ultrasound Renal Denervation System | The CE-marked and commercially available ReCor Medical Paradise Ultrasound Renal Denervation System (Paradise System) is a catheter-based device designed to use ultrasound energy to thermally ablate the nerves surrounding the renal artery and serving the kidney. |
Timeline
- Start date
- 2022-01-13
- Primary completion
- 2030-12-31
- Completion
- 2031-12-31
- First posted
- 2021-08-30
- Last updated
- 2023-07-07
Locations
35 sites across 7 countries: Belgium, France, Germany, Monaco, Netherlands, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT05027685. Inclusion in this directory is not an endorsement.