Status:
TERMINATED
Connected Catheter- Safety and Effectiveness Study
Lead Sponsor:
Spinal Singularity
Conditions:
Urinary Retention
Neurogenic Bladder
Eligibility:
MALE
18+ years
Phase:
NA
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...
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 i...
Eligibility Criteria
Inclusion
- Males age ≥ 18 with clinical diagnosis of significant urinary retention
- Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy
- Must have stable urinary management history as determined by the Investigator
- OR:
- Must have urodynamic profile suitable for the Gen 2 Connected Catheter (including bladder capacity \> 200mL without uninhibited bladder contractions)
- Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Gen 2 Connected Catheter device, as specified in the Investigational Device Instructions for use (IFU)
Exclusion
- Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the 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 (uncontrolled) autonomic dysreflexia (AD)
- Significant intermittent urinary incontinence (between catheterizations)
- Uninhibited bladder contractions and/or Vesicoureteral 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 and urine analysis)
- 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
- 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
- Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications
- Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System
- Catheter Assessment Tool screening yields unacceptable results
Key Trial Info
Start Date :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03843073
Start Date
October 16 2020
End Date
April 6 2021
Last Update
November 23 2021
Active Locations (9)
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1
West Coast Urology, 11411 Brookshire Avenue, Suite 508
Downey, California, United States, 90241
2
West Coast Urology, 575 E. Hardy St., Suite 215
Inglewood, California, United States, 90301
3
Tri Valley Urology, 25495 Medical Center Dr., Suite 204
Murrieta, California, United States, 92562
4
Chesapeake Urology
Owings Mills, Maryland, United States, 21117