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Clinical Trial Summary

The objective of this study is to evaluate the safety and essential performance of the Connected Catheter System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting, and during and extended period (up to 29 days) of home use.


Clinical Trial Description

The Connected Catheter (C2P) is a replaceable urinary prosthesis that is intended for use in male patients 18 years of age or older who have impaired bladder emptying due to neurogenic lower urinary tract dysfunction, and who are capable of operating the device in accordance with the provided instructions for use, or who have trained caregivers capable of doing the same. The device must be replaced every 29 days ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03405285
Study type Interventional
Source Spinal Singularity
Contact
Status Completed
Phase N/A
Start date February 28, 2018
Completion date June 30, 2018

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