Connected Catheter - Safety and Effectiveness Study

Technology
Bladder health
Online since 11 November 2022, updated 472 days ago

About this trial

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...

Included participants

Gender
Male
Age
≥ 18 years
Injury level
Level not specified
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    No
    Level not specified

    What’s involved

    Type

    Technology

    Details

    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.

    Potential benefits

    Main benefits

    Bladder health

    Additional benefits

    General health

    Mental health

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Oct 2020
    • Organisation
    • Spinal Singularity
    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Oct 2020
    • Organisation
    • Spinal Singularity

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more