NCT02746419

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Autosomal Dominant Polycystic Kidney Disease

Interventions

Type	Name	Description
DEVICE	Vessix	Renal denervation using radio-ablation

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-05-01
• Completion: 2020-05-01
• First posted: 2016-04-21
• Last updated: 2019-04-03

Regulatory

• FDA-regulated device study