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

Primary Purpose

Hypertension, Uncontrolled Hypertension

Status
Active
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
Renal Pelvic Denervation (bilateral)
Sponsored by
Verve Medical, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Off-med group: (1) Ambulatory mean daytime SBP ≥140 mmHg in patients never treated for hypertension or after being taken off anti-hypertension medications for 4 weeks before ambulatory blood pressure assessment. (2) Ambulatory daytime SBP and DBP less than 170/105 mmHg. (3) Subjects will not be on ANY anti-hypertension medications or will be willing to discontinue current anti-hypertension medications.
  • On-med group: (1) Subjects who are currently taking 1, 2, or 3 anti-hypertensive medications. (2) Ambulatory mean daytime SBP ≥135 mmHg. (3) Ambulatory daytime SBP and DBP less than 170/105 mmHg.

Exclusion Criteria:

  • Females who are either pregnant or breastfeeding.
  • Office SBP or DBP ≥180/110 mmHg.
  • Untreated urinary tract infection.
  • Renal collecting system is compromised, and subject cannot undergo routine cystoscopy and retrograde pyelogram.
  • Dialysis patients.
  • Renal transplant patients.
  • Subjects on the following medications, clonidine, guanfacine and methyldopa.
  • Known secondary causes of hypertension such as adrenal disease, renal artery stenosis, renovascular hypertension.
  • Subjects with glomerulonephritis or interstitial nephritis or eGFR < 45 ml/min/1.73m2.
  • Type I diabetes mellitus.
  • Stenotic valvular heart disease for which reduction of blood pressure would be hazardous.
  • Subjects with orthostatic hypotension.
  • Myocardial infarction, unstable angina, or stroke in the prior 6 months.
  • Any medical condition (including psychiatric disease) that would interfere with conducting the study or would not be in the best interest of the subject.
  • Inability of the subject to provide informed consent.
  • Subjects with sleep apnea.
  • Patients taking any drugs that affect blood pressure through off target effects
  • Patients with any clinical condition that can affect blood pressure or require the use of drugs that can affect blood pressure. e.g. NSAIDs, steroids, cold remedies.
  • Patients who may require any procedure that can affect blood pressure.
  • Patients who work a night shift.

Sites / Locations

  • Israeli-Georgian Medical Research Clinic Helsicore
  • Pineo Medical Ecosystem

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal Pelvic Denervation

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in mean daytime systolic blood pressure
Mean daytime systolic blood pressure determined from ambulatory blood pressure monitoring

Secondary Outcome Measures

Change in mean 24-hour systolic blood pressure
Mean 24-hour systolic blood pressure determined from ambulatory blood pressure monitoring
Change in automated office systolic blood pressure
Automated office blood pressure measured after resting and in triplicate
Safety of renal pelvic denervation
Number of subjects with serious adverse events, treatment-emergent adverse events and adverse events assessed, including evidence for acute kidney injury and hypertension-related morbidity

Full Information

First Posted
June 23, 2022
Last Updated
June 30, 2022
Sponsor
Verve Medical, Inc
Collaborators
Clinical Accelerator (CRO), Israeli-Georgian Medical Research Clinic Helsicore, Pineo Medical Ecosystem
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1. Study Identification

Unique Protocol Identification Number
NCT05440513
Brief Title
A Study of Non-Vascular Renal Denervation Using the Verve Medical Phoenix ™ System
Acronym
TUSK
Official Title
Trans Ureteral Sympathectomy of the Kidney Study Using the Verve Medical Phoenix ™ System
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
February 5, 2022 (Actual)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Verve Medical, Inc
Collaborators
Clinical Accelerator (CRO), Israeli-Georgian Medical Research Clinic Helsicore, Pineo Medical Ecosystem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Uncontrolled Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal Pelvic Denervation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Renal Pelvic Denervation (bilateral)
Other Intervention Name(s)
renal nerve ablation, renal sympathectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean daytime systolic blood pressure
Description
Mean daytime systolic blood pressure determined from ambulatory blood pressure monitoring
Time Frame
Month 2
Secondary Outcome Measure Information:
Title
Change in mean 24-hour systolic blood pressure
Description
Mean 24-hour systolic blood pressure determined from ambulatory blood pressure monitoring
Time Frame
Month 2
Title
Change in automated office systolic blood pressure
Description
Automated office blood pressure measured after resting and in triplicate
Time Frame
Month 2
Title
Safety of renal pelvic denervation
Description
Number of subjects with serious adverse events, treatment-emergent adverse events and adverse events assessed, including evidence for acute kidney injury and hypertension-related morbidity
Time Frame
Month 2
Other Pre-specified Outcome Measures:
Title
Effect on renal function
Description
Effects on serum creatinine
Time Frame
Month 2
Title
Effect on index of renal function
Description
Effects on estimated glomerular filtration rate
Time Frame
Month 2
Title
Effects on ABPM at month 6 (durability of effects)
Description
ABPM performed during follow-up
Time Frame
Through month 6
Title
Effects on ABPM month 12 (durability of effects)
Description
ABPM performed during follow-up
Time Frame
Through month 12
Title
Effects on OBM at month 6 (durability of effects)
Description
OBP performed during follow-up
Time Frame
Through month 6
Title
Effects on OBP at month 12 (durability of effects)
Description
OBP performed during follow-up
Time Frame
Through month 12
Title
Safety of renal pelvic denervation
Description
Number of subjects with serious adverse events, treatment-emergent adverse events and adverse events assessed, including evidence of acute kidney injury
Time Frame
Through month 6
Title
Safety of renal pelvic denervation
Description
Number of subjects with serious adverse events, treatment-emergent adverse events and adverse events assessed, including evidence of acute kidney injury
Time Frame
Through month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Off-med group: (1) Ambulatory mean daytime SBP ≥140 mmHg in patients never treated for hypertension or after being taken off anti-hypertension medications for 4 weeks before ambulatory blood pressure assessment. (2) Ambulatory daytime SBP and DBP less than 170/105 mmHg. (3) Subjects will not be on ANY anti-hypertension medications or will be willing to discontinue current anti-hypertension medications. On-med group: (1) Subjects who are currently taking 1, 2, or 3 anti-hypertensive medications. (2) Ambulatory mean daytime SBP ≥135 mmHg. (3) Ambulatory daytime SBP and DBP less than 170/105 mmHg. Exclusion Criteria: Females who are either pregnant or breastfeeding. Office SBP or DBP ≥180/110 mmHg. Untreated urinary tract infection. Renal collecting system is compromised, and subject cannot undergo routine cystoscopy and retrograde pyelogram. Dialysis patients. Renal transplant patients. Subjects on the following medications, clonidine, guanfacine and methyldopa. Known secondary causes of hypertension such as adrenal disease, renal artery stenosis, renovascular hypertension. Subjects with glomerulonephritis or interstitial nephritis or eGFR < 45 ml/min/1.73m2. Type I diabetes mellitus. Stenotic valvular heart disease for which reduction of blood pressure would be hazardous. Subjects with orthostatic hypotension. Myocardial infarction, unstable angina, or stroke in the prior 6 months. Any medical condition (including psychiatric disease) that would interfere with conducting the study or would not be in the best interest of the subject. Inability of the subject to provide informed consent. Subjects with sleep apnea. Patients taking any drugs that affect blood pressure through off target effects Patients with any clinical condition that can affect blood pressure or require the use of drugs that can affect blood pressure. e.g. NSAIDs, steroids, cold remedies. Patients who may require any procedure that can affect blood pressure. Patients who work a night shift.
Facility Information:
Facility Name
Israeli-Georgian Medical Research Clinic Helsicore
City
Tbilisi
Country
Georgia
Facility Name
Pineo Medical Ecosystem
City
Tbilisi
Country
Georgia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34038910
Citation
Hering D, Hubbard BS, Weber MA, Heuser RR. Impact of Renal Pelvic Denervation on Systemic Hemodynamics and Neurohumoral Changes in a Porcine Model. Am J Nephrol. 2021;52(5):429-434. doi: 10.1159/000516186. Epub 2021 May 26.
Results Reference
background
PubMed Identifier
36254733
Citation
Hering D, Nikoleishvili D, Imedadze A, Dughashvili G, Klimiashvili Z, Bekaia E, Shengelia T, Kobalava M, Goguadze O, Emukhvari T, Druker V, Sackner-Bernstein J, Weber MA. Transurethral Renal Pelvic Denervation: A Feasibility Trial in Patients with Uncontrolled Hypertension. Hypertension. 2022 Dec;79(12):2787-2795. doi: 10.1161/HYPERTENSIONAHA.122.20048. Epub 2022 Oct 18.
Results Reference
derived

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

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