Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-24 @ 1:57 PM
NCT ID:
NCT01638195
Eligibility Criteria:
Inclusion Criteria:
* Subject is at least 18 years of age.
* Subject has systolic blood pressure of 160 mmHg or greater.
* Subject has refractory, stable hypertension despite being treated with at least three hypertensive drugs.
* Subject has two functioning kidneys, defined as eGFR ≥ 60 ml/min.
Exclusion Criteria:
* Subject has history of nephrectomy, kidney tumor or hydronephrosis.
* Subject has renal stenosis greater than 50%.
* Subject has presence of accessory renal artery with lumen ≥ 3 mm.
* Subject has a renal stent.
* Subject has end stage renal disease requiring dialysis or renal implant.
* Subject has Serum Cr \> 3.0 mg/dL or equivalent calculated Glomerular Filtration Rate (GFR).
* Subject has a history of kidney stones.
* Subject has a history of abdominal surgery.
* Subject has a history of heterogeneities in the kidney such as cysts or tumors.
* Subject has a history of pyelonephritis.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01638195
Study Brief:
Protocol Section:
NCT01638195