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Connected Catheter (C2P) Study for Bladder Management

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ClinicalTrials.gov Identifier: NCT03626324
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : September 12, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : September 30, 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



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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


Contacts
Contact: William Colone 9494367974 bill@spinalsingularity.com
Contact: Shannon Metzger 9494367974 Shannon@spinalsingularity.com

Locations
United States, Arizona
Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104 Recruiting
Peoria, Arizona, United States, 85351
Contact: Linda Garber    623-546-0715    lgarber.nwu@arizonaccc.com   
Principal Investigator: Ian L. Goldman, MD         
Northwest Urology Associates, 14674 W. Mountain View Blvd, Suite 210 Recruiting
Surprise, Arizona, United States, 85374
Contact: Linda Garber    623-546-0715    lgarber.nwu@arizonaccc.com   
Principal Investigator: Ian L Goldman, MD         
United States, California
West Coast Urology, 11411 Brookshire Avenue, Suite 508 Recruiting
Downey, California, United States, 90241
Contact: Tiffany Aynehchi    562-923-0706    tiffany@westcoasturology.com   
Principal Investigator: Ernest Agatstein, MD         
West Coast Urology, 575 E. Hardy St., Suite 215 Recruiting
Inglewood, California, United States, 90301
Contact: Tiffany Aynehchi    562-923-0706    tiffany@westcoasturology.com   
Principal Investigator: Ernest Agatstein, MD         
Tri Valley Urology, 25495 Medical Center Dr., Suite 204 Recruiting
Murrieta, California, United States, 92562
Contact: Anita Deeds    951-698-1901 ext 232    anita@trivalleyurology.com   
Principal Investigator: Sreenivas Vemulapalli, MD         
United States, Minnesota
Minnesota Urology, 6025 Lake Road Suite 200 Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Diane Kachel    651-999-7033    DKachel@mnurology.com   
Principal Investigator: Steven Siegel, MD         
United States, New Jersey
New Jersey Urology, 15000 Midlantic Drive, Suite 100 Recruiting
Mount Laurel, New Jersey, United States, 08054
Contact: Renee Haney    856-840-4563    rhaney@dvullc.com   
Principal Investigator: Thomas Mueller, MD         
New Jersey Urology, 2401 Evesham Road, Suite F Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Renee Haney    856-673-1613    rhaney@dvullc.com   
Principal Investigator: Thomas Mueller, MD         
Sponsors and Collaborators
Spinal Singularity
Investigators
Study Director: Derek Herrera Spinal Singularity

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: September 12, 2018
Last Verified: September 2018

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:
Urinary Retention
Urinary Bladder, Neurogenic
Urination Disorders
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Signs and Symptoms