Connected Catheter- Safety and Effectiveness Study
Stopped early · Not applicable
Conditions studied: Urinary Retention, Neurogenic Bladder, Urologic Diseases
In brief
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.
Key facts
- Study ID
- NCT03843073
- Run by
- Spinal Singularity
- People needed
- 9
- Starts
- 2020-10-16
- Expected to finish
- 2021-04-06
- Last updated by the study team
- 2021-11-23
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- West Coast Urology, 11411 Brookshire Avenue, Suite 508 — Downey, California, United States
- West Coast Urology, 575 E. Hardy St., Suite 215 — Inglewood, California, United States
- Tri Valley Urology, 25495 Medical Center Dr., Suite 204 — Murrieta, California, United States
- Chesapeake Urology — Owings Mills, Maryland, United States
- Minnesota Urology, 6025 Lake Road Suite 200 — Woodbury, Minnesota, United States
- New Jersey Urology, 15000 Midlantic Drive, Suite 100 — Mount Laurel, New Jersey, United States
- New Jersey Urology, 2401 Evesham Road, Suite F — Voorhees Township, New Jersey, United States
- Dr. Jonathan Vapnek Urology — New York, New York, United States
- Urology San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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