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Connected Catheter Clinical Feasibility Study( CFS)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03405285
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : September 26, 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 Connected Catheter System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting, and during and extended period (up to 29 days) of home use.

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

Detailed Description:
The Connected Catheter (C2P) is a replaceable urinary prosthesis that is intended for use in male patients 18 years of age or older who have impaired bladder emptying due to neurogenic lower urinary tract dysfunction, and who are capable of operating the device in accordance with the provided instructions for use, or who have trained caregivers capable of doing the same. The device must be replaced every 29 days

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of Connected Catheter Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
Actual Study Start Date : February 28, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Arm Intervention/treatment
Experimental: Connected Catheter Feasibility Study
Clinical Feasibility Evaluation of Connected Catheter Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
Device: Connected Catheter
The Connected Catheter 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 CoCath 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: 29 Days ]
    Improved bladder management without injury or trauma to genito-urinary tract

  2. Successful Acute Performance- I [ Time Frame: On the day of Connected Catheter Insertion ]
    To evaluate successful retention of Connected Catheter and Void

  3. Successful Acute Performance -II [ Time Frame: On the day of Connected Catheter Insertion ]
    To evaluate successful bladder voiding with Connected Catheter

  4. Successful Acute Performance- III [ Time Frame: On the day of Connected Catheter Insertion ]
    To evaluate successful removal of Connected Catheter

  5. Successful Acute Performance- IV [ Time Frame: On the day of Connected Catheter Insertion ]
    To evaluate successful post-void sealing of Connected Catheter Valve

  6. Successful Home-Use Performance [ Time Frame: 29 days ]
    Successful Home-Use using same measures as Acute Performance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Males age ≥ 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction (NLUTD)
  • Must be clinically suitable and capable of safely managing bladder using an intermittent voiding strategy Must have stable urinary management history with clean intermittent catheterization: no significant changes in bladder management regimen within past 12 months

OR:

Must have urodynamic profile suitable for CIC, as assessed via urodynamics study within past 12 months (including bladder capacity > 200mL without uninhibited bladder contractions)

  • Subject's lower urinary tract anatomy (lengths of proximal and distal urethral must fall within the ranges serviceable by the Connected Catheter device, as specified in the investigational device instructions for use.
  • For cases of NLUTD due to spinal cord injury, the subject must be in medically stable condition (i.e. post-spinal shock phase)

Exclusion Criteria:

  • Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the CoCath Device after UTI has been treated)
  • Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days)
  • Significant risk profile or recent history of clinically significant autonomic dysreflexia (e.g. History of hospitalization due to AD within past 12 months)
  • Significant intermittent urinary incontinence (between catheterizations)
  • Uninhibited bladder contractions and/or vesico-ureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. botox injections)
  • Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy, urine analysis, and blood labs)
  • Urinary tract inflammation or neoplasm
  • Urinary fistula
  • Bladder diverticulum (outpouching) > 5cm in size
  • Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
  • Impaired kidney function or renal failure (assessed via blood creatinine levels > 2 mg/dL)
  • Active gross hematuria
  • Active urethritis
  • Bladder stones
  • Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
  • Individuals allergic or otherwise unable to take oral antibiotics
  • Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the CoCath 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): NCT03405285


Locations
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United States, California
West Coast Urology, 11411 Brookshire Avenue, Suite 508
Downey, California, United States, 90241
Tri Valley Urology, 25495 Medical Center Dr., Suite 204
Murrieta, California, United States, 92562
Sponsors and Collaborators
Spinal Singularity
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Responsible Party: Spinal Singularity
ClinicalTrials.gov Identifier: NCT03405285    
Other Study ID Numbers: CoCath-01
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Improved Bladder Management
Neurogenic Lower Urinary Tract Dysfunction
Bladder function following Spinal Cord Injury
Urinary Retention
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms