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Trial record 2 of 531 for:    catheter | Urologic Diseases

Connected Catheter- Evaluation Study

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ClinicalTrials.gov Identifier: NCT03843073
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Spinal Singularity

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, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.

Condition or disease Intervention/treatment Phase
Urinary Retention Neurogenic Bladder Urologic Diseases Device: Connected Urinary Catheter Not Applicable

Detailed Description:
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.

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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
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: Connected Catheter Users Device: Connected Urinary Catheter
Patients will use the Connected Catheter to empty the bladder during the course of treatment.




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

  2. Successful Bladder Emptying Using Connected Catheter [ Time Frame: 35-40 days ]
    Rate of successful voiding with Connected Catheter as assessed by Post-Residual Volume (PVR) measurement via ultrasound

  3. Freedom from Symptomatic Urinary Tract Infection (UTI) [ Time Frame: 35-40 days ]
    Rate of Symptomatic UTI while using the Connected Catheter.



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Ages Eligible for Study:   18 Years to 90 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
  10. Catheter Assessment Tool screening yields unacceptable results

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, Florida
Clinical Research Center of Florida Recruiting
Pompano Beach, Florida, United States, 33060
Contact: Jack Herman, MD    954-941-3330    jack@floridacrc.com   
Principal Investigator: Steven Kester, 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, Nebraska
Adult & Pediatric Urology Recruiting
Omaha, Nebraska, United States, 68114
Contact: Amy Nelson    402-399-7892    anelson@adultpediatricuro.com   
Principal Investigator: Andrew Arthur, MD         
United States, New Jersey
New Jersey Urology, 15000 Midlantic Drive, Suite 100 Recruiting
Mount Laurel, New Jersey, United States, 08054
Contact: Jennifer Pilallis    856-673-1613    jpilallis@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         
United States, New York
Dr. Jonathan Vapnek Urology Recruiting
New York, New York, United States, 10075
Contact: Jonathan Vapnek, MD    212-717-9500    jvapnek@rcn.com   
United States, Texas
Urology San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Kethsaly Salinas    210-617-4116    kethsaly.salinas@urologysa.com   
Principal Investigator: David Talley, MD         
Sponsors and Collaborators
Spinal Singularity

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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: September 5, 2019
Last Verified: September 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 Bladder, Neurogenic
Urinary Retention
Urologic Diseases
Urination Disorders
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Signs and Symptoms