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Connected Catheter (C2P) Study for Bladder Management

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ClinicalTrials.gov Identifier: NCT03626324
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Spinal Singularity

Tracking Information
First Submitted Date  ICMJE July 26, 2018
First Posted Date  ICMJE August 13, 2018
Last Update Posted Date February 8, 2019
Actual Study Start Date  ICMJE July 25, 2018
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • Freedom from genito-urinary injury/trauma [ Time Frame: 3 months ]
    Improved bladder management without injury to genito-urinary tract
  • Successful Acute Performance- I [ Time Frame: Day 0 (On the day of C2P insertion) ]
    To evaluate successful retention of C2P
  • Successful Acute Performance- II [ Time Frame: Day 0 (On the day of C2P insertion) ]
    To evaluate successful bladder voiding with C2P
  • Successful Acute Performance- III [ Time Frame: Day 0 (On the day of C2P insertion) ]
    To evaluate successful valve sealing of C2P
  • Successful Home-use Performance [ Time Frame: 3 months ]
    To evaluate successful home use of C2P using same measures as Acute Performance
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03626324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Connected Catheter (C2P) Study for Bladder Management
Official Title  ICMJE Clinical Evaluation of Connected Catheter 2P (C2P) Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
Brief 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.
Detailed 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Urinary Retention
  • Neurogenic Bladder
Intervention  ICMJE Device: C2P
The C2P is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization, including neurogenic lower urinary tract dysfunction (NLUTD - e.g. due to spinal cord injury). The C2P is a sterile, single-extended-use device that resides fully internally to the male lower urinary tract (urethra + bladder neck) for an intended service life of up to 29 days per Catheter.
Study Arms  ICMJE Experimental: C2P Study
Clinical Evaluation of Connected Catheter 2P Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
Intervention: Device: C2P
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2019)
27
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2018)
80
Actual Study Completion Date  ICMJE January 31, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males age ≥ 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction (NLUTD)
  2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy

    • Must have stable urinary management history: no significant changes in bladder management regimen within past 12 months

    OR:

    • Must have urodynamic profile suitable for C2P, as assessed via urodynamics study within past 12 months (including bladder capacity > 200mL without uninhibited bladder contractions)
  3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the C2P device, as specified in the investigational device instructions for use (IFU).

Exclusion Criteria:

  1. Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the device after Urinary Tract Infection (UTI) has been treated)
  2. Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days)
  3. Significant risk profile or recent history of clinically significant autonomic dysreflexia (AD) (e.g. History of hospitalization due to AD within past 12 months)
  4. Significant intermittent urinary incontinence (between catheterizations)
  5. Uninhibited bladder contractions and/or vesico-ureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injections)
  6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis)
  7. Urinary tract inflammation or neoplasm
  8. Urinary fistula
  9. Bladder diverticulum (outpouching) > 5cm in size
  10. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
  11. Impaired kidney function or renal failure
  12. Active gross hematuria
  13. Active urethritis
  14. Bladder stones
  15. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
  16. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications
  17. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the C2P System
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03626324
Other Study ID Numbers  ICMJE C2P-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spinal Singularity
Study Sponsor  ICMJE Spinal Singularity
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Derek Herrera Spinal Singularity
PRS Account Spinal Singularity
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP