HypertensionTUSKNCT05440513
A Study of Non-Vascular Renal Denervation Using the Verve Medical Phoenix ™ System
A study testing Renal Pelvic Denervation (bilateral) in people with Hypertension and Uncontrolled Hypertension, run by Verve Medical, Inc at 2 sites in Georgia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension, Uncontrolled Hypertension
- What is being tested?
- Renal Pelvic Denervation (bilateral)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesGeorgia
- Study dates
- 25 Jan 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Georgia2 sites
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi
Pineo Medical Ecosystem
Tbilisi
About this study
Official title: Trans Ureteral Sympathectomy of the Kidney Study Using the Verve Medical Phoenix ™ System
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.
Read the 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
- Being tested
- Renal Pelvic Denervation (bilateral)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Pelvic Denervation (bilateral)Device
Also called renal nerve ablation, renal sympathectomy
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.
| Study group | Role | What they receive |
|---|---|---|
| Renal Pelvic Denervation | Experimental | 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. Receives: Device: Renal Pelvic Denervation (bilateral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean daytime systolic blood pressure
Mean daytime systolic blood pressure determined from ambulatory blood pressure monitoring
Measured: Month 2
Secondary outcomes (3)
Change in mean 24-hour systolic blood pressure
Mean 24-hour systolic blood pressure determined from ambulatory blood pressure monitoring
Measured: Month 2
Change in automated office systolic blood pressure
Automated office blood pressure measured after resting and in triplicate
Measured: Month 2
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
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start25 Jan 2021
- Primary completion5 Feb 2022
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verve Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Accelerator, Israeli-Georgian Medical Research Clinic Helsicore, Pineo Medical Ecosystem
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440513
- Sponsor's protocol ID
- CP0002
- Acronym
- TUSK
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34038910Weber MA, Hering D, Nikoleishvili D, Imedadze A, Dughashvili G, Klimiashvili Z, Bekaia E, Shengelia T, Kabalava M, Goguadze O, Emukhvari T, Druker V, Buelna T, Heuser R, Hashemian S, Provanzano R. Durability of the Blood Pressure Effects of Renal Pelvic Denervation in Patients with Hypertension during a 12-Month Observation. Am J Nephrol. 2024;55(3):319-328. doi: 10.1159/000533569. Epub 2023 Aug 31.
PubMed 37651994Hering 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.
PubMed 36254733
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans Ureteral Sympathectomy of the Kidney Study Using the Verve Medical Phoenix ™ System
- ClinicalTrials.gov ID
- NCT05440513
- Acronym / sponsor ID
- TUSK / CP0002
- Conditions
- Hypertension, Uncontrolled Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Verve Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Accelerator, Israeli-Georgian Medical Research Clinic Helsicore, Pineo Medical Ecosystem
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 5 Feb 2022 (actual)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Pelvic Denervation | Experimental | 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal Pelvic Denervation (bilateral)Also: renal nerve ablation, renal sympathectomyUsing 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. | Device | Renal Pelvic Denervation |
Primary outcome
Change in mean daytime systolic blood pressure
Time frame: Month 2
Mean daytime systolic blood pressure determined from ambulatory blood pressure monitoring
3 secondary outcomes
Change in mean 24-hour systolic blood pressure
Time frame: Month 2
Change in automated office systolic blood pressure
Time frame: Month 2
Safety of renal pelvic denervation
Time frame: Month 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Background: PubMed 34038910Hering 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.
- Derived from this study: PubMed 37651994Weber MA, Hering D, Nikoleishvili D, Imedadze A, Dughashvili G, Klimiashvili Z, Bekaia E, Shengelia T, Kabalava M, Goguadze O, Emukhvari T, Druker V, Buelna T, Heuser R, Hashemian S, Provanzano R. Durability of the Blood Pressure Effects of Renal Pelvic Denervation in Patients with Hypertension during a 12-Month Observation. Am J Nephrol. 2024;55(3):319-328. doi: 10.1159/000533569. Epub 2023 Aug 31.
- Derived from this study: PubMed 36254733Hering 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal Pelvic Denervation (bilateral) in people with Hypertension and Uncontrolled Hypertension, run by Verve Medical, Inc at 2 sites in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean daytime systolic blood pressure (time frame: Month 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05440513, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.