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Connected Catheter- Evaluation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03843073
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Spinal Singularity

Tracking Information
First Submitted Date  ICMJE February 7, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date July 24, 2020
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
  • Improved bladder management without injury to genito-urinary tract [ Time Frame: 35-40 days ]
    Rate of genito-urinary injury/trauma when using Connected Catheter
  • 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
  • Freedom from Symptomatic Urinary Tract Infection (UTI) [ Time Frame: 35-40 days ]
    Rate of Symptomatic UTI while using the Connected Catheter.
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • Improved bladder management without injury to genito-urinary tract [ Time Frame: 35-40 days ]
    Absence of genito-urinary injury/trauma when using Connected Catheter
  • Successful Connected Catheter Acute Retention (Acute Performance- I) [ Time Frame: Day 0 ( On the day of Connected Catheter Insertion) ]
    Successful retention of Connected Catheter
  • 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
  • Successful Connected Catheter Valve Sealing (Acute Performance- III) [ Time Frame: Day 0 ( On the day of Connected Catheter Insertion) ]
    Absence of significant urinary incontinence
Change History
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- Evaluation Study
Official Title  ICMJE Clinical Evaluation of the Connected Catheter- Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Urinary Retention
  • Neurogenic Bladder
  • Urologic Diseases
Intervention  ICMJE Device: Connected Urinary Catheter
Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Study Arms  ICMJE Experimental: Connected Catheter Users
Intervention: Device: Connected Urinary Catheter
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shannon Metzger 949-436-7974 shannon@spinalsingularity.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03843073
Other Study ID Numbers  ICMJE ES-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: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spinal Singularity
Study Sponsor  ICMJE Spinal Singularity
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Spinal Singularity
Verification Date July 2020

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