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A Study of Non-Vascular Renal Denervation Using the Verve Medical Phoenix ™ System

NCT05440513 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-07-06

No results posted yet for this study

Summary

The aim of the study is to assess the safety and effectiveness of a novel device for renal denervation to lower blood pressure in people with uncontrolled hypertension. Prior studies demonstrate the potential benefit of renal denervation in hypertension, though these studies primarily denervate the kidneys by passing catheters through the arteries in the groin into the renal arteries. The TUSK study utilizes the Phoenix system to perform denervation by advancing the device (a thin electrode) through the urinary tract into the kidneys where radiofrequency energy is briefly applied to denervate the kidneys.

Conditions

Interventions

DEVICE

Renal Pelvic Denervation (bilateral)

Using the natural orifice of the urethra, the ureters are accessed (bilaterally and in sequence), to allow for an ablation device to be placed into the renal pelvis where RF energy is delivered to ablate renal nerves.

Sponsors & Collaborators

  • Clinical Accelerator

    collaborator INDUSTRY

  • Israeli-Georgian Medical Research Clinic Helsicore

    collaborator UNKNOWN

  • Pineo Medical Ecosystem

    collaborator UNKNOWN

  • Verve Medical, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2022-02-05
Completion
2022-12-15
FDA Device
Yes

Countries

  • Georgia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05440513 on ClinicalTrials.gov