At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 19 enrolled
Drug / intervention
Celsius® ThermoCool® Renal Denervationdevice
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-II - 157)
In Brief
A Phase 1 clinical trial evaluating Celsius® ThermoCool® Renal Denervation for Hypertension, Renal. Completed, enrolled 19 participants.
Detailed Summary
This is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Renal
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
Primary CompletionMar 2014
First PostedMar 2014
Study CompletionApr 2015
TodayJul 2026
First PostedMar 26, 2014
Enrollment StartOct 1, 2013
Primary CompletionMar 1, 2014
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.3 years ago
Interventions
Celsius® ThermoCool® Renal Denervationdevice
The investigational device is indicated for the treatment of resistant hypertension by renal denervation.