Renal Pelvic Denervation Pilot Trial

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Verve Medical, Inc
Study ID
NCT07005050
Status
Recruiting
Apply to this trial

Conditions

  • Uncontrolled Hypertension

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • RPD — DEVICE
    Renal Pelvic Denervation
  • Active hypertension medical therapy — DRUG
    Prespecified two medication regimen for control of hypertension

Study Details

The RPD Pilot trial will evaluate the safety and effectiveness of Verve Medical's RPDTM renal denervation system for hypertensive patients with uncontrolled blood pressure despite use of two medications at a therapeutic dose. The novelty of the RPDTM system relates to its placement via natural orifice into the renal pelvis (bilaterally) for delivery of radiofrequency energy to ablate the nerves that pass through the outer wall of the renal pelvis, a technique referred to as renal pelvic denervation (RPD).

Key Dates

Start date
Dec 30, 2025
Status verified
Jan 2026
Primary completion
Oct 30, 2026
Completion
Mar 2, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: RPD arm
    The Verve RPD™ system is used to perform renal pelvic denervation via the urinary collecting system for the treatment of hypertension. The system does so through the delivery of RF energy to the walls of the renal pelvis - delivered via natural orifice through the urinary tract. During the course of the study, patients will be on active medical therapy for their hypertension.
  • Sham Comparator: Sham arm
    Sham procedure will include all steps employed in the renal pelvis denervation with exception of activation of the RPD™ Device. Sham procedure includes advancing guidewire, cystoscope and sheath to position within the renal pelvis, then deploying the RPD™ Device into the renal pelvis (within each kidney), keeping the device in place for 2 minutes (within each kidney) to simulate activation, and then withdrawing the device and sheath. During the course of the study, sham patients will be on active medical therapy for their hypertension.

Primary Outcome Measure

Primary effectiveness [ Time Frame: 2 months post treatment ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Maria El Hachem
[email protected]
Eric Judd, MD (PRINCIPAL_INVESTIGATOR)
Panoramic Health / Southwest Kidney Institute, PLCSurpriseArizona85374
Minesh Rajpal, MD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55455
Kathryn Vera
[email protected]
John Osborn (PRINCIPAL_INVESTIGATOR)
Sabine Karam (SUB_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Marie Hogan (PRINCIPAL_INVESTIGATOR)
DaVita Clinical ResearchLas VegasNevada89107
Tetiana Kolomoiets
[email protected]
Mark Vishnepolsky, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALPanoramic Health / Southwest Kidney Institute, PLC· Surprise, AZUniversity of Minnesota· Minneapolis, MNMayo Clinic· Rochester, MNDaVita Clinical Research· Las Vegas, NV

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