Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-27 @ 10:07 PM
Study NCT ID:
NCT01638195
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2012-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Evaluation of Renal Denervation Using Focused Therapeutic Ultrasound on Patients With Refractory Hypertension
Sponsor:
Kona Medical Inc.
Organization:
Study Overview
Official Title:
A Feasibility Study: A Safety Evaluation of Renal Denervation Using Focused Therapeutic Ultrasound on Patients With Refractory Hypertension
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective, single-institution trial wherein twenty subjects with refractory hypertension will receive the experimental focused ultrasound renal denervation therapy. Safety will be assessed by incidence and evaluation of serious adverse effects associated with the investigational procedure through 52-week evaluation of bilateral treatment. Clinical utility will also be evaluated by comparison pre and post therapy systolic and diastolic blood pressure and norepinephrine spillover.
Detailed Description:
This study is a prospective, single-institution trial wherein each included subject will receive the experimental focused ultrasound renal denervation therapy. It will be conducted on a maximum of twenty adult male or female patients who meet the inclusion and exclusion 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 of bilateral treatment. Clinical utility is the secondary endpoint of this study. Clinical utility will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure and norepinephrine (NE) spillover.
The study has been designed so that subjects are treated in a careful and stepwise fashion in order to minimize the potential risks associated with the investigational therapy. After completing baseline testing, the investigational focused ultrasound therapy will be unilaterally administered. Each subject is first treated on the right side. Renal angiograms are obtained after treatment is completed to ensure any resulting complications are quickly identified. After three weeks of treatment, the subject is further evaluated again with blood tests, EKG, angiogram and a norepinephrine spillover test. If any complications that preclude participation in the study are revealed, then additional treatment is halted. Upon safe treatment of the right renal artery, the left renal artery is then treated. Safety and functional evaluation occurs three weeks, and three and six months after completion of the last treatment. This sequential unilateral treatment scheme minimizes the potential risks to any given subject.
The second key factor in designing this study is the stepwise progression of applying the investigational therapy dose. Low dosing levels with established safety profile will first be applied before administering higher dosing levels. The low dosing level will be administered to the first ten subjects. The specified low dosing level was selected because it is just above the threshold value where renal denervation was detectable in the swine model, and patients participating in this cohort are expected to benefit from modest levels of renal neurolysis as measured by the norepinephrine spillover test. Only after five of the first ten subjects have been safely treated and evaluated at the 3-week follow-up evaluation may the remaining ten subjects (i.e., subjects #11 - 20) be treated with the higher dosing treatment. The specified higher dosing level was selected to induce increased renal neurolysis and thereby enable the expected escalated-dose response to be measured.
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 of bilateral treatment. Clinical utility is the secondary endpoint of this study. Clinical utility will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure and norepinephrine (NE) spillover.
The study has been designed so that subjects are treated in a careful and stepwise fashion in order to minimize the potential risks associated with the investigational therapy. After completing baseline testing, the investigational focused ultrasound therapy will be unilaterally administered. Each subject is first treated on the right side. Renal angiograms are obtained after treatment is completed to ensure any resulting complications are quickly identified. After three weeks of treatment, the subject is further evaluated again with blood tests, EKG, angiogram and a norepinephrine spillover test. If any complications that preclude participation in the study are revealed, then additional treatment is halted. Upon safe treatment of the right renal artery, the left renal artery is then treated. Safety and functional evaluation occurs three weeks, and three and six months after completion of the last treatment. This sequential unilateral treatment scheme minimizes the potential risks to any given subject.
The second key factor in designing this study is the stepwise progression of applying the investigational therapy dose. Low dosing levels with established safety profile will first be applied before administering higher dosing levels. The low dosing level will be administered to the first ten subjects. The specified low dosing level was selected because it is just above the threshold value where renal denervation was detectable in the swine model, and patients participating in this cohort are expected to benefit from modest levels of renal neurolysis as measured by the norepinephrine spillover test. Only after five of the first ten subjects have been safely treated and evaluated at the 3-week follow-up evaluation may the remaining ten subjects (i.e., subjects #11 - 20) be treated with the higher dosing treatment. The specified higher dosing level was selected to induce increased renal neurolysis and thereby enable the expected escalated-dose response to be measured.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: