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Procedure
Renal Denervation for Loin Pain-Hematuria Syndrome
N/A
Waitlist Available
Led By Bhanu Prasad, MD
Research Sponsored by Saskatchewan Health Authority - Regina Area
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 18 years of age
Current use of prescription pain medication for LPHS treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of procedure (for each patient) to 6 months after the procedure
Awards & highlights
Study Summary
This trial is to study if a minimally invasive alternative to opiate therapy, auto-transplantation and nephrectomy is effective in LPHS. The study will be double-blinded, parallel group, sham-controlled, and randomized controlled trial (RCT).
Who is the study for?
This trial is for adults over 18 with Loin Pain Hematuria Syndrome, diagnosed by a nephrologist and urologist, who are currently on prescription pain meds. Participants must have certain artery sizes and can't join if they've had kidney transplants, are pregnant/nursing, have specific kidney issues or vascular abnormalities, need chronic oxygen support, or have a history of renal procedures.Check my eligibility
What is being tested?
The study tests the Symplicity Spyral™ system's ability to perform radiofrequency nerve ablation as an alternative to opioids or surgery in LPHS patients. It's a double-blinded trial comparing this treatment against a sham procedure to see if it's feasible for larger trials.See study design
What are the potential side effects?
While not explicitly listed here, side effects may include discomfort at the site of intervention, potential damage to blood vessels from the angiogram or denervation device, bleeding complications post-procedure and possible worsening of hypertension.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am currently taking prescription pain medication for LPHS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of procedure (for each patient) to 6 months after the procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of procedure (for each patient) to 6 months after the procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess the of proportion of randomized participants (treatment or control) who entirely complete the follow-up measures
Assess the proportion of participants undergo procedures (treatment or sham) within 6 months
Secondary outcome measures
To assess the change from Baseline CES-D score at 6 months after procedure (treatment or control)
To assess the change from Baseline EQ-5D VAS at 6 months after procedure (treatment or control)
To assess the change from Baseline McGill Pain score at 6 months after procedure (treatment or control)
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Renal angiography and Renal denervationExperimental Treatment2 Interventions
Symplicity Spyral™ multi electrode renal denervation system
After renal angiography, participants in the experimental group will be immediately treated with renal denervation procedure using standard techniques. The participants will remain blinded throughout the procedure.
Group II: Renal angiographyPlacebo Group1 Intervention
In the control group, the sham procedure will consist of only a renal angiogram. Participants will undergo diagnostic renal angiogram but will not receive any therapeutic endovascular treatment. Participants will remain on the procedure table for at least 20 min after the angiogram to prevent possible unblinding of randomization allocation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Renal angiogram
2011
N/A
~540
Find a Location
Who is running the clinical trial?
University of SaskatchewanOTHER
251 Previous Clinical Trials
154,146 Total Patients Enrolled
Saskatchewan Health Authority - Regina AreaLead Sponsor
27 Previous Clinical Trials
5,414 Total Patients Enrolled
Bhanu Prasad, MDPrincipal InvestigatorSaskatchewan Health Authority - Regina Area
1 Previous Clinical Trials
26 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You have been diagnosed with a somatoform disorder using the SCID-5 assessment.I have been diagnosed with loin pain hematuria syndrome by kidney and urinary tract doctors.My kidney function is reduced, with an eGFR below 45.I need help breathing, like oxygen support or a ventilator.You have had surgery or have devices in your kidneys or aorta.I am currently taking prescription pain medication for LPHS.My arteries are between 3 mm and 8 mm wide.I have had a kidney auto transplantation.I have abnormalities in the blood vessels of my kidneys.
Research Study Groups:
This trial has the following groups:- Group 1: Renal angiography and Renal denervation
- Group 2: Renal angiography
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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