← Back to Search

Procedure

Renal Denervation for Loin Pain-Hematuria Syndrome

N/A

Recruiting

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of procedure (for each patient) to 6 months after the procedure for reporting.

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 more

Trial 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of SaskatchewanOTHER

251 Previous Clinical Trials

154,400 Total Patients Enrolled

Saskatchewan Health Authority - Regina AreaLead Sponsor

27 Previous Clinical Trials

5,508 Total Patients Enrolled

Bhanu Prasad, MDPrincipal InvestigatorSaskatchewan Health Authority - Regina Area

1 Previous Clinical Trials

26 Total Patients Enrolled

Media Library

Symplicity Spyral™ multi electrode renal denervation system (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04332731 — N/A

Loin Pain-Hematuria Syndrome Research Study Groups: Renal angiography and Renal denervation, Renal angiography

Loin Pain-Hematuria Syndrome Clinical Trial 2023: Symplicity Spyral™ multi electrode renal denervation system Highlights & Side Effects. Trial Name: NCT04332731 — N/A

Symplicity Spyral™ multi electrode renal denervation system (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04332731 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor accepting elderly individuals as participants?

"As stipulated in the study criteria, potential participants must be above 18 years old and below 80."

Answered by AI

What is the paramount aim of this clinical trial?

"This clinical trial aims to measure the number of participants (treatment or control) who fully complete the follow-up measures within a 6 month period. Secondary objectives include recording and comparing baseline morphine-equivalent daily medication dosage, McGill Pain scores, and Oswestry Disability Index ratings at both Baseline and 6 months after procedure for treatment/control groups."

Answered by AI

How many participants have been approved to be involved with this experiment?

"Affirmative. Clinicaltrials.gov data indicate that this medical research venture, initially posted on December 1st 2020, is currently recruiting participants. This study requires 10 patients from a single site to join its trial."

Answered by AI

Is this research accepting new participants?

"Affirmative, the particulars hosted on clinicaltrials.gov verify that this medical research is actively recruiting volunteers. It was first posted December 1st 2020 and has been updated May 3rd 2022; 10 enrollees are needed across a single site."

Answered by AI

What criteria must individuals meet to be qualified for this investigation?

"Interested individuals must meet two criteria in order to qualify for this clinical trial: they should present symptoms of hematuria and be aged between 18-80. This study is currently recruiting 10 participants."

Answered by AI

Recent research and studies

Canadian Journal of Kidney Health and DiseaseJournal

Feasibility Study of a Randomized Controlled Trial Investigating Renal Denervation as a Possible Treatment Option in Patients with Loin Pain Hematuria Syndrome

Prasad, Bhanu, Maryam Jafari, Kaval Kour, Kunal Goyal, and Francisco Garcia. 2020. “Feasibility Study of a Randomized Controlled Trial Investigating Renal Denervation as a Possible Treatment Option in Patients with Loin Pain Hematuria Syndrome”. Canadian Journal of Kidney Health and Disease. SAGE Publications. doi:10.1177/2054358120951390.

American Journal of Kidney DiseasesJournal

Renal Denervation in Patients with Loin Pain Hematuria Syndrome

Prasad, Bhanu, Shelley Giebel, Francisco Garcia, Kunal Goyal, and Jennifer Rose St. Onge. 2017. “Renal Denervation in Patients with Loin Pain Hematuria Syndrome”. American Journal of Kidney Diseases. Elsevier BV. doi:10.1053/j.ajkd.2016.06.016.

Kidney International ReportsJournal

Successful Use of Renal Denervation in Patients with Loin Pain Hematuria Syndrome—the Regina Loin Pain Hematuria Syndrome Study

Prasad, Bhanu, Shelley Giebel, Francisco Garcia, Kunal Goyal, Pratima Shrivastava, and Warren Berry. 2018. “Successful Use of Renal Denervation in Patients with Loin Pain Hematuria Syndrome—the Regina Loin Pain Hematuria Syndrome Study”. Kidney International Reports. Elsevier BV. doi:10.1016/j.ekir.2018.01.006.

clinicaltrials.govStudy