Connected Catheter- Safety and Effectiveness Study

  • STATUS
    Recruiting
  • days left to enroll
    72
  • participants needed
    90
  • sponsor
    Spinal Singularity
Updated on 21 March 2021

Summary

The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.

Description

Spinal Singularity has developed the Connected Catheter System to address several drawbacks of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. Each subject will use the Connected Catheter for up to 35-40 days. This includes five device exchange appointments. The appointments are spaced 7 days apart and at each appointment the catheter will be replaced with a new one. Additionally, weekly follow-up will occur for 14 days following the final appointment after the subject discontinues use of study device and reverts to his original catheter.

Details
Condition Neurogenic Bladder, URINARY TRACT DISORDER, bladder disorder, Urinary Retention, Bladder Disorders, Chronic Urinary Retention, uropathy, urinary tract disorders, urinary tract disease, urological disease, urological diseases
Treatment Connected Urinary Catheter
Clinical Study IdentifierNCT03843073
SponsorSpinal Singularity
Last Modified on21 March 2021

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