HypertensionNCT01704170
Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound
A study testing Kona Externally Focused Ultrasound Therapy in people with Hypertension, run by Kona Medical Inc. at 4 sites in 3 countries.
Trial summary
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 fifty patients who meet the inclusion and exclusion criteria and have signed the informed consent form. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Kona Externally Focused Ultrasound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Nov 2012to Jun 2014
- 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
- Subject is at least 18 years of age.
- Subject has systolic blood pressure of 160 mmHg in average or greater.
- Subject has refractory, stable hypertension despite being treated with at least three hypertensive drugs.
- Subject has two functioning kidneys, defined as eGFR ≥ 45 ml/min.
- Subject has at least one renal artery on each side which is greater than 4mm.
Who cannot join
- Subject has hydronephrosis as seen on MRA or ultrasound.
- Subject has renal stenosis greater than 50% based on baseline MRA.
- Subject has a renal stent or other implant in the region.
- Subject has kidney stones which are symptomatic and/or greater than 1cm or in the discretion of the investigator may interfere with treatment.
- Subject has a history of abdominal surgery within the past six months.
- Subject has heterogeneities in the kidney such as large cysts or tumors which in the discretion of the investigator may interfere with treatment.
Show all 15Show fewer
- Subject has active pyelonephritis or a history of pyelonephritis which in the discretion of the investigator may interfere with treatment.
- Subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
- Subject has hemodynamically significant valvular heart disease.
- Subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with MRI.
- Subject has a body weight > 150 kilograms.
- Subject has a target treatment depth > 14 cm.
- Subject is pregnant, nursing or intends to become pregnant during the trial period.
- Subject is currently enrolled in other potentially confounding research.
- Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 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 on Patients With Refractory Hypertension
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 fifty patients who meet the inclusion and exclusion criteria and have signed the informed consent form. Safety is the primary endpoint of this study and 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 the secondary endpoint of this study and will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure.
- Conditions
- Hypertension
- Being tested
- Kona Externally Focused Ultrasound Therapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kona Externally Focused Ultrasound TherapyDevice
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation Using Externally Focused Ultrasound Therapy | Experimental | Not described Receives: Device: Kona Externally Focused Ultrasound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of Adverse Events through 52 week follow-up
Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation of bilateral treatment. Included in this assessment will be the proportion of subjects with any of the following outcomes: (1) death, or (2) medical morbidity, including but not limited to renal artery aneurysm, stenosis, significant deterioration of renal function, fistulae or ureteral stenosis.
Measured: One Year
Secondary outcomes (1)
Decrease in Blood Pressure
Clinical utility will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure.
Measured: 12 and 24 weeks post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2014
- Study completionJun 2014
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
- 31 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
- NCT01704170
- Sponsor's protocol ID
- KM12-001
- Status last verified
- Apr 2015
- First submitted
- 8 Oct 2012
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 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 on Patients With Refractory Hypertension
- ClinicalTrials.gov ID
- NCT01704170
- Acronym / sponsor ID
- KM12-001
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Kona Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Oct 2012 (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 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 fifty patients who meet the inclusion and exclusion criteria and have signed the informed consent form. Safety is the primary endpoint of this study and 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 the secondary endpoint of this study and will be evaluated by assessing 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 Using Externally Focused Ultrasound Therapy | Experimental | Device: Kona Externally Focused 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)
- Subject is at least 18 years of age.
- Subject has systolic blood pressure of 160 mmHg in average or greater.
- Subject has refractory, stable hypertension despite being treated with at least three hypertensive drugs.
- Subject has two functioning kidneys, defined as eGFR ≥ 45 ml/min.
- Subject has at least one renal artery on each side which is greater than 4mm.
Key exclusion criteria (15 listed)
- Subject has hydronephrosis as seen on MRA or ultrasound.
- Subject has renal stenosis greater than 50% based on baseline MRA.
- Subject has a renal stent or other implant in the region.
- Subject has kidney stones which are symptomatic and/or greater than 1cm or in the discretion of the investigator may interfere with treatment.
- Subject has a history of abdominal surgery within the past six months.
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 |
|---|---|---|
| Kona Externally Focused Ultrasound Therapy | Device | Renal Denervation Using Externally Focused Ultrasound Therapy |
Primary outcome
Safety: Incidence of Adverse Events through 52 week follow-up
Time frame: One Year
Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation of bilateral treatment. Included in this assessment will be the proportion of subjects with any of the following outcomes: (1) death, or (2) medical morbidity, including but not limited to renal artery aneurysm, stenosis, significant deterioration of renal function, fistulae or ureteral stenosis.
1 secondary outcome
Decrease in Blood Pressure
Time frame: 12 and 24 weeks post therapy
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 13 Apr 2015.
Related trials for Hypertension
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kona Externally Focused Ultrasound Therapy in people with Hypertension, run by Kona Medical Inc. at 4 sites in 3 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 15 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 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia, Australia, Canada. 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: Incidence of Adverse Events through 52 week follow-up (time frame: One Year). 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 13 Apr 2015.