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Trial record 24 of 25 for:    Spinal Cord Injuries | ( Map: Minnesota, United States )

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

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.

Condition or disease Intervention/treatment Phase
Urinary Retention Neurogenic Bladder Device: C2P Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of Connected Catheter 2P (C2P) Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
Actual Study Start Date : July 25, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Arm Intervention/treatment
Experimental: C2P Study
Clinical Evaluation of Connected Catheter 2P Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
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.




Primary Outcome Measures :
  1. Freedom from genito-urinary injury/trauma [ Time Frame: 3 months ]
    Improved bladder management without injury to genito-urinary tract

  2. Successful Acute Performance- I [ Time Frame: Day 0 (On the day of C2P insertion) ]
    To evaluate successful retention of C2P

  3. Successful Acute Performance- II [ Time Frame: Day 0 (On the day of C2P insertion) ]
    To evaluate successful bladder voiding with C2P

  4. Successful Acute Performance- III [ Time Frame: Day 0 (On the day of C2P insertion) ]
    To evaluate successful valve sealing of C2P

  5. Successful Home-use Performance [ Time Frame: 3 months ]
    To evaluate successful home use of C2P using same measures as Acute Performance



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626324


Locations
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United States, Arizona
Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104
Peoria, Arizona, United States, 85351
Northwest Urology Associates, 14674 W. Mountain View Blvd, Suite 210
Surprise, Arizona, United States, 85374
United States, California
West Coast Urology, 11411 Brookshire Avenue, Suite 508
Downey, California, United States, 90241
West Coast Urology, 575 E. Hardy St., Suite 215
Inglewood, California, United States, 90301
Tri Valley Urology, 25495 Medical Center Dr., Suite 204
Murrieta, California, United States, 92562
United States, Minnesota
Minnesota Urology, 6025 Lake Road Suite 200
Woodbury, Minnesota, United States, 55125
United States, New Jersey
New Jersey Urology, 15000 Midlantic Drive, Suite 100
Mount Laurel, New Jersey, United States, 08054
New Jersey Urology, 2401 Evesham Road, Suite F
Voorhees, New Jersey, United States, 08043
Sponsors and Collaborators
Spinal Singularity
Investigators
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Study Director: Derek Herrera Spinal Singularity

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Responsible Party: Spinal Singularity
ClinicalTrials.gov Identifier: NCT03626324     History of Changes
Other Study ID Numbers: C2P-01
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spinal Singularity:
Spinal Cord Injury (SCI)
Neurogenic Lower Urinary Tract Dysfunction (NLUTD)
Catheter associated Urinary Tract Infection (CAUTI)
Urinary Catheters
Dementia
Stroke
Diabetes
Parkinson's
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Urinary Retention
Urination Disorders
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Signs and Symptoms