A Study of Quality of Life and Pain Control Before and After Endovascular Renal Denervation in Individuals with Refractory Kidney Pain

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-007496
    Sponsor Protocol Number: 16-007496

About this study

The purpose of this study is to examine patient reported outcomes including pain, quality of life, depression and impact on kidney blood flow before and after procedure to destroy the pain sensory nerves of the kidneys in patients with untreatable one or two sided kidney pain.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Must be able to provide informed consent
  • Willing to participate in pain rehabilitation and pain management programs provided here at Mayo Clinic or elsewhere
  • Has had chronic debilitating kidney pain for >6 months
  • Other approaches to pain management will have been appropriately considered and used when indicated and feasible as deemed by the PI
  • Meets objective measures as assessed by opiate dependence or unwillingness to take opiates, partial or full medical disability or decreased quality of life
  • Must be able to travel to site
  • Ideal candidates will have (unilateral or bilateral) single renal arteries and lack a hemodynamically significant renal artery stenosis and presence of suitable renal artery calibers of 4-7mm
  • Screening CT angiogram of renal arteries provides sufficient renal imaging to exclude genitourinary obstruction, tumor, surgically active nephrolithiasis or other clinically significant pathologies associated with kidney pain
    • CTA will specifically delineate renal anatomy and presence of low accessory arteries (not always seen-special imaging cuts will be performed to identify such cases)

Exclusion Criteria

  • Has renal artery anatomy that is ineligible for treatment including
    • Lacks at least one renal artery for each kidney with ≥ 4 mm diameter and with ≥ 20 mm treatable length prior to a significant arterial branch
    • Renal artery stenosis (>50%) or renal artery aneurysm in renal artery
    • A history of prior renal artery intervention including balloon angioplasty or stenting
    • Renal arteries which contain calcification or abnormality which does not allow at least 4 RF ablations
  • Has a confounding medical condition which may adversely affect the safety of the participant in the opinion of the PI
  • Unable to provide informed consent in the opinion of the PI or collaborator

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Marie Hogan, M.D., Ph.D.

Open for enrollment

Contact information:

Marie Hogan M.D., Ph.D.

(507)284-2944

Hogan.Marie@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20301666

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