NCT05440513

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

Trans Ureteral Sympathectomy of the Kidney Study Using the Verve Medical Phoenix ™ System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Verve Medical, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Up to 20 patients with uncontrolled hypertension will be treated with the PhoenixTM renal pelvic denervation system, whether or not receiving background medical therapy. Qualification will be based on documented uncontrolled hypertension by 24-hour ambulatory blood pressure monitoring. Those qualifying will be expected to maintain their medical therapy without changes until after the primary effectiveness assessment two months later. Following baseline testing, patients will undergo renal pelvic denervation under anesthesia and remain in the hospital overnight. The denervation device is inserted through the urethra into each kidney and all devices are removed at the completion of the procedure. Radiofrequency energy is administered for a single 2-minute treatment period in each kidney. Follow up visits will extend to one year. Patients will complete medication logs along with repeat assessment of blood pressure in office and via 24-hour ambulatory blood pressure monitor. Follow up testing will also include imaging studies of the kidneys.

Conditions

• Hypertension
• Uncontrolled Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-25
• Primary completion: 2022-02-05
• Completion: 2022-12-15
• First posted: 2022-07-01
• Last updated: 2022-07-06

Locations

2 sites across 1 country: Georgia

Regulatory

• FDA-regulated device study