Trials / Completed
CompletedNCT04248530
DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study
An Open-Label, Single Arm, Multicenter Feasibility Study to Evaluate the Safety of Catheter-Based Renal Denervation With the DENEX System in Patients With Uncontrolled Hypertension on Standard Medical Therapy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Kalos Medical · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The study is the multicenter pilot study to obtain an assessment of the safety of renal denervation in the patients with uncontrolled hypertension on standard medical therapy in Korea.
Detailed description
DENEX system developed by Handok Kalos Medical Inc. is a renal nerve blocking system to efficiently block the sympathetic nerve of the kidney with minimal invasive procedure. It was developed to block the sympathetic nerves distributed in blood vessel wall by delivering high frequency energy to the renal artery for the purpose of treating hypertension.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Renal denervation | DENEX catheter is a device to treat resistant hypertension which delivers high-frequency energy through the three electrodes connected to the catheter in order to cauterize sympathetic nerve bundle. |
Timeline
- Start date
- 2016-11-30
- Primary completion
- 2019-07-01
- Completion
- 2020-05-07
- First posted
- 2020-01-30
- Last updated
- 2022-06-22
Locations
5 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04248530. Inclusion in this directory is not an endorsement.