A Phase 3 interventional study of Dehydrated Alcohol Injection, USP and Sham procedure in Hypertension and Hypertension,Essential, sponsored by Ablative Solutions, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Ablative Solutions, Inc. · Phase 3, Interventional, and Treatment
To obtain an assessment of the efficacy and safety of renal denervation by dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter in hypertensive subjects in the absence of antihypertensive medications.
This Phase 3, prospective, randomized, blinded, sham procedure-controlled, multicenter study will assess the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Catheter in hypertensive subjects in the absence of antihypertensive medications. Subjects with a documented history of uncontrolled hypertension who are taking 0, 1, or 2 antihypertensive medications at enrollment will be recruited. After providing written informed consent, subjects will undergo screening assessments to assess eligibility for the study. Eligible subjects will then enter a run-in period during which they will take no antihypertensive medications. Subjects who continue to be eligible at the end of the run-in period will complete the study Baseline visit and remain without taking antihypertensive medications. Subjects who continue to be eligible after the completion of the Baseline visit will attend the study site and will be randomized to either the Treatment Arm (renal denervation using the Peregrine Catheter) or the Sham Control Arm (renal angiography only).
After study unblinding, crossover from the Sham Control Arm to the Treatment Arm may be allowed, at the discretion of the treating investigator.
478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.
This study's planned enrollment of 202 is above the median of 144 across 406 interventional studies indexed under Essential Hypertension.
Browse Essential Hypertension studies →Ablative Solutions, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Compared within Essential Hypertension, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypertension. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Renal denervation performed with dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter.
Drug: Dehydrated Alcohol Injection, USP
Only renal angiography performed
Procedure: Sham procedure
Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
Also known as: Alcohol
Endovascular, renal angiography
Changes in Systolic Ambulatory Blood Pressure at 8 weeks
Change from baseline in mean 24-hour ambulatory systolic blood pressure
Time frame: Baseline to 8 weeks post-treatment
Change in Office SBP at 8 Weeks
Change from Baseline in mean office SBP to Week 8
Time frame: Baseline to 8 weeks post-treatment
Change in Office DBP at 8 Weeks
Change from Baseline in mean office DBP to Week 8
Time frame: Baseline to 8 weeks post-treatment
Changes in Diastolic Ambulatory Blood Pressure at 8 Weeks
Change from baseline in mean 24-hour ambulatory diastolic blood pressure at 8 weeks post-procedure
Time frame: Baseline to 8 weeks post-treatment
Changes in Systolic Ambulatory Blood Pressure at 6 Months
Change from baseline in mean 24-hour ambulatory systolic blood pressure at 6 months post-procedure
Time frame: Baseline to 6 months post-treatment
Changes in Diastolic Ambulatory Blood Pressure at 6 Months
Change from baseline in mean 24-hour ambulatory diastolic blood pressure at 6 months post-procedure
Time frame: Baseline to 6 months post-treatment
Changes in Mean Daytime Ambulatory SBP at 8 Weeks
Change from baseline in mean daytime systolic blood pressure at 8 weeks post-procedure
Time frame: Baseline to 8 weeks post-treatment
Changes in Mean Daytime Ambulatory SBP at 6 Months
Change from baseline in mean daytime systolic blood pressure at 6 months post-procedure
Time frame: Baseline to 6 months post-treatment
Changes in Mean Daytime Ambulatory DBP at 8 Weeks
Change from baseline in mean daytime diastolic blood pressure at 8 weeks post-procedure
Time frame: Baseline to 8 weeks post-treatment
Changes in Mean Daytime Ambulatory DBP at 6 Months
Change from baseline in mean daytime diastolic blood pressure at 6 months post-procedure
Time frame: Baseline to 6 months post-treatment
Changes in Mean Nighttime Ambulatory SBP at 8 Weeks
Change from baseline in mean nighttime systolic blood pressure at 8 weeks post-procedure
Time frame: Baseline to 8 weeks post-treatment
Changes in Mean Nighttime Ambulatory SBP at 6 Months
Change from baseline in mean nighttime systolic blood pressure at 6 months post-procedure
Time frame: Baseline to 6 months post-treatment
Changes in Mean Nighttime Ambulatory DBP at 8 Weeks
Change from baseline in mean nighttime diastolic blood pressure at 8 weeks post-procedure
Time frame: Baseline to 8 weeks post-treatment
Changes in Mean Nighttime Ambulatory DBP at 6 Months
Change from baseline in mean nighttime DBP at 6 months post-procedure
Time frame: Baseline to 6 months post-treatment
Change in Office SBP at 6 Months
Change from Baseline in mean office SBP at 6 months post-procedure
Time frame: Baseline to 6 months post-treatment
Change in Office DBP at 6 Months
Change from Baseline in mean office DBP to Week 8 at 6 months post-procedure
Time frame: Baseline to 6 months post-treatment
Use of Antihypertensive Medication(s) at 8 Weeks
Use of antihypertensive medication at 8 weeks post-procedure
Time frame: 8 weeks post-treatment
Use of antihypertensive medication(s) from 8 Weeks to 6 Months
Change in use of antihypertensive medication(s) from 8 Weeks to 6 Months post procedure (titrated according to standardized formula to maintain a target SBP of \<140 mmHg and ≥90 mmHg)
Time frame: 6 months post-treatment
Number of Participants With Major Adverse Events (MAEs)
Number of participants with major adverse events (MAEs) 30 days post-procedure
Time frame: 30 days post-treatment
Change in Home SBP at 8 Weeks
Change from Baseline in mean home SBP at 8 weeks post-procedure
Time frame: 8 weeks post-treatment
Change in Home SBP at 6 months
Change from Baseline in mean home SBP at 6 months post-procedure
Time frame: 6 months post-treatment
Change in Home DBP at 8 Weeks
Change from Baseline in mean home DBP at 8 weeks post-procedure
Time frame: 8 weeks post-treatment
Change in Home DBP at 6 months
Change from Baseline in mean home DBP at 6 months post-procedure
Time frame: 6 months post-treatment
Start is estimated for Oct 2026; primary completion for May 2028, 19 months later.
Of 45 industry-sponsored phase 3 interventional studies under Essential Hypertension, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 24. This study's planned 19 months is above that.
Counting every sponsor, half of 47 studies reached it within 17 months; a quarter within 11 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ethanol
Ablative Solutions, Inc.