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Connected Catheter- Evaluation Study

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ClinicalTrials.gov Identifier: NCT03843073
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Spinal Singularity

Study Description
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Brief 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, 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 7 days per Catheter

Condition or disease Intervention/treatment Phase
Chronic Urinary Retention Device: Connected Urinary Catheter Not Applicable

Detailed Description:
Spinal Singularity had developed Connected Catheter System to address several drawbacks of current standard-of-care urinary catheters. The Connected Catheter is fully internal, urethral 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 routine follow-up appointments. The follow-up 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.

Study Design
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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 the Connected Catheter- Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arms and Interventions
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Arm Intervention/treatment
Experimental: Connected Catheter Evaluation Study
Clinical Evaluation of the Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
 Device: Connected Urinary Catheter
The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with chronic urinary retention disorders requiring catheterization. . The Connected Catheter 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 7 days per Catheter.


Outcome Measures
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Primary Outcome Measures :
  1. Improved bladder management without injury to genito-urinary tract [ Time Frame: 35-40 days ]
    Absence of genito-urinary injury/trauma when using Connected Catheter

  2. Successful Connected Catheter Acute Retention (Acute Performance- I) [ Time Frame: Day 0 ( On the day of Connected Catheter Insertion) ]
    Successful retention of Connected Catheter

  3. Successful Bladder Emptying Using Connected Catheter (Acute Performance- II) [ Time Frame: Day 0 ( On the day of Connected Catheter Insertion) ]
    Successful voiding with Connected Catheter as assessed by Post-Residual Volume (PVR) measurement via ultrasound

  4. Successful Connected Catheter Valve Sealing (Acute Performance- III) [ Time Frame: Day 0 ( On the day of Connected Catheter Insertion) ]
    Absence of significant urinary incontinence


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (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 significant urinary retention

  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 Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions)

  3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Connected Catheter, as specified in the Investigational Device Instructions for use (IFU)

Exclusion Criteria:

  1. Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the device after 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 (uncontrolled) autonomic dysreflexia (AD)
  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)

    1. Urinary tract inflammation or neoplasm
    2. Urinary fistula
    3. Bladder diverticulum (outpouching) > 5cm in size
    4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
    5. Impaired kidney function or renal failure
    6. Active gross hematuria
    7. Active urethritis
    8. Bladder stones
  7. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
  8. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications
  9. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System -
Contacts and Locations
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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): NCT03843073


Contacts
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Contact: William Colone 949-436-7974 bill@spinalsingularity.com
Contact: Shannon Metzger 949-436-7974

Locations
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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         
Orange County Urology Associates/Research Alliance Recruiting
Laguna Hills, California, United States, 92653
Contact: Justin Deck    949-680-3490    jdeck@researchalliance.com   
Principal Investigator: Leah Nakamura, 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, Colorado
The Urology Center of Colorado Recruiting
Denver, Colorado, United States, 80211
Contact: Chris Lightsey    303-762-7154    clightsey@tucc.com   
Principal Investigator: Lawerence Karsh, MD         
United States, Maryland
Chesapeake Urology Recruiting
Owings Mills, Maryland, United States, 21117
Contact: Rayna Bennett-Campbell    443-231-1203    rbennett@chesuro.com   
Principal Investigator: Andrew Shapiro, MD         
United States, Minnesota
Minnesota Urology, 6025 Lake Road Suite 200 Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Diane Kachel    651-999-7032    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
More Information
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Responsible Party: Spinal Singularity
ClinicalTrials.gov Identifier: NCT03843073     History of Changes
Other Study ID Numbers: ES-01
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 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
 Urinary Retention
Enlarged Prostate
Prostate cancer

Additional relevant MeSH terms:
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Urinary Retention
Urination Disorders
Urologic Diseases