At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 35 enrolled
Drug / intervention
Celsius® ThermoCool® RDdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multi-Center, Non-Randomized Feasibility Study of Catheter-Based Renal Denervation to Treat Resistant Hypertension (RENABLATE- EC12-02)
In Brief
A Phase 1 clinical trial evaluating Celsius® ThermoCool® RD for Hypertension, Renal. Completed, enrolled 35 participants.
Detailed Summary
The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of the investigational multi-electrode ablation catheter and integrated ablation system to treat resistant hypertension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Renal
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2012
First PostedDec 2012
Primary CompletionNov 2013
Study CompletionApr 2015
TodayJul 2026
First PostedDec 25, 2012
Enrollment StartDec 1, 2012
Primary CompletionNov 1, 2013
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.5 years ago
Interventions
Celsius® ThermoCool® RDdevice
The investigational device is designed to transmit radiofrequency (RF) current to the electrodes for ablation purposes, specifically for the treatment of resistant hypertension by renal denervation.