Clinical Trial: The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix™ Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patients With Severe Debilitating Pain

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix™ Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patien

Brief Summary: This study will test the safety and efficacy of the Vessix Renal Denervation system in the reduction of pain in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Detailed Summary: This study will employ the Vessix Renal Denervation System (Boston Scientific) to ablate the renal nerve by radio-ablation in patients suffering from severe pain due to Autosomal Dominant Polycystic Kidney Disease (ADPKD). Twenty patients with opiate-dependent, Autosomal Dominant Polycystic Kidney Disease-associated kidney pain will be selected to this double-blind, prospective device study. Subjects will be randomly assigned to an experimental (those who will receive nerve ablation) or control (those who will have a sham procedure in which the ablation device is not turned on) groups. Subjects will complete physical exams and be administered questionnaires regarding their mental status and pain before, during and after the denervation procedure. Renal function and adverse events will be monitored for 1 year after denervation.
Sponsor: University of Chicago

Current Primary Outcome: Number of adverse events [ Time Frame: 6 months ]

Adverse events will be recorded over a 6 month time period (post-procedure) for all subjects. The average number of adverse events in the experimental group will be compared to that of the control (sham) group.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in pain [ Time Frame: 12 months ]
    Pain reduction will be measured over a 12 month period at post-procedure by a Visual Analog Scale pain questionnaire. The average change in pain score in the experimental group will be compared to the average change in pain score in the control (sham) group.
  • Change in renal function [ Time Frame: 2 weeks ]
    Glomerular filtration rate (GFR) will be measured as a test for renal function two weeks after procedure. Change in GFR from experimental group will be compared to the change in GFR from control group
  • Change in Quality of life as measured by quality of life questionnaire [ Time Frame: 12 months ]
    Quality of life will be measured over a 12 month period at using an Autosomal Dominant Polycystic Kidney Disease quality of life questionnaires. Change in scores for questionnaires for experimental group at will be compared to those in control group
  • Change in Quality of life as measured by depression questionnaire [ Time Frame: 12 months ]
    Change in quality of life will be measured using a depression questionnaire. Scores for experimental group will be compared to those in control group


Original Secondary Outcome: Same as current

Information By: University of Chicago

Dates:
Date Received: April 8, 2016
Date Started: January 2017
Date Completion: May 2020
Last Updated: October 24, 2016
Last Verified: October 2016