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Clinical Trial Summary

The objective of this study is to evaluate the safety and essential performance of the C2P System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting and an extended period of home use.


Clinical Trial Description

Spinal Singularity had developed C2P system to address several drawbacks of current standard-of-care urinary catheters. The C2P is fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization, including NLUTD. The C2P is a sterile, single-extended use device that resides fully internally to the male lower urinary tract for an intended service life of up to 29 days per catheter ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03626324
Study type Interventional
Source Spinal Singularity
Contact
Status Completed
Phase N/A
Start date July 25, 2018
Completion date January 31, 2019

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