HypertensionNCT01926951
Renal Denervation Using Externally Focused Therapeutic Ultrasound
A study testing Surround Sound Externally Focused Therapeutic Ultrasound in people with Hypertension, run by Kona Medical Inc. at 3 sites in 2 countries.
Trial summary
This study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Surround Sound Externally Focused Therapeutic Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2013to Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Average systolic blood pressure at least 160 mmHg
- Refractory, stable hypertension despite being treated with at least three hypertensive drugs
- Two functioning kidneys, defined as eGFR >= 45 ml/min
- At least one renal artery on each side which is greater than 4 mm.
Who cannot join
- History of nephrectomy or hydronephrosis
- Renal stenosis > 50%
- Renal stent
- Ambulatory blood pressure monitoring 24 hour average systolic blood pressure <= 135 mmHg
- Kidney stones which are symptomatic and/or > 1 cm
- History of abdominal surgery within the past 6 months
Show all 14Show fewer
- Heterogeneities in the kidneys (cysts or tumors)
- Residual pyelonephritis
- History of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last 6 months
- Hemodynamically significant valvular heart disease
- Implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with MRI
- Body weight > 150 kilograms
- Target treatment depth > 14 cm from the skin line
- Pregnant, nursing or intends to become pregnant during the trial period
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Czechia2 sites
St. Anne's University Hospital
Brno
Nemocnice Na Homolee Hospital
Prague
About this study
Official title: A Feasibility Study: An Evaluation of Renal Denervation Using Externally Focused Therapeutic Ultrasound With External Targeting and Tracking on Patients With Refractory Hypertension
This study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension.
Read the detailed description
This study is a prospective, multi-center trial wherein each included subject will receive the experimental externally focused ultrasound renal denervation therapy. It will be conducted on a maximum of twenty patients who meet the eligibility criteria and have signed the informed consent form.
Safety is the primary endpoint of this study. Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation. Clinical utility is a secondary endpoint of this study. Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.
- Conditions
- Hypertension
- Being tested
- Surround Sound Externally Focused Therapeutic Ultrasound
- Keywords
- hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surround Sound Externally Focused Therapeutic UltrasoundDevice
Externally Focused Therapeutic Ultrasound using the Kona Surround Sound System
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | Renal Denervation using the Kona Surround Sound Externally Focused Therapeutic Ultrasound therapy. Receives: Device: Surround Sound Externally Focused Therapeutic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through 52-week evaluation. Included in this assessment will be the proportion of subjects with any of the following outcomes: 1) death, or 2) medical morbidity.
Measured: 52-week post-treatment
Secondary outcomes (1)
Clinical Utility
Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.
Measured: 52-week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kona Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926951
- Sponsor's protocol ID
- KM13-001
- Status last verified
- Oct 2015
- First submitted
- 19 Aug 2013
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study: An Evaluation of Renal Denervation Using Externally Focused Therapeutic Ultrasound With External Targeting and Tracking on Patients With Refractory Hypertension
- ClinicalTrials.gov ID
- NCT01926951
- Acronym / sponsor ID
- KM13-001
- Conditions
- Hypertension
- Keywords
- hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kona Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Aug 2013 (estimated)
- 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.
This study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension.
Detailed description
This study is a prospective, multi-center trial wherein each included subject will receive the experimental externally focused ultrasound renal denervation therapy. It will be conducted on a maximum of twenty patients who meet the eligibility criteria and have signed the informed consent form.
Safety is the primary endpoint of this study. Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation. Clinical utility is a secondary endpoint of this study. Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Experimental | Device: Surround Sound Externally Focused Therapeutic UltrasoundRenal Denervation using the Kona Surround Sound Externally Focused Therapeutic Ultrasound therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Average systolic blood pressure at least 160 mmHg
- Refractory, stable hypertension despite being treated with at least three hypertensive drugs
- Two functioning kidneys, defined as eGFR >= 45 ml/min
- At least one renal artery on each side which is greater than 4 mm.
Key exclusion criteria (14 listed)
- History of nephrectomy or hydronephrosis
- Renal stenosis > 50%
- Renal stent
- Ambulatory blood pressure monitoring 24 hour average systolic blood pressure <= 135 mmHg
- Kidney stones which are symptomatic and/or > 1 cm
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 |
|---|---|---|
| Surround Sound Externally Focused Therapeutic UltrasoundExternally Focused Therapeutic Ultrasound using the Kona Surround Sound System | Device | Renal Denervation |
Primary outcome
Safety
Time frame: 52-week post-treatment
Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through 52-week evaluation. Included in this assessment will be the proportion of subjects with any of the following outcomes: 1) death, or 2) medical morbidity.
1 secondary outcome
Clinical Utility
Time frame: 52-week post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surround Sound Externally Focused Therapeutic Ultrasound in people with Hypertension, run by Kona Medical Inc. at 3 sites in 2 countries.
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 5 inclusion and 14 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: finished, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, New Zealand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety (time frame: 52-week post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.