Connected Catheter- Safety and Effectiveness Study (NCT03843073) | Clinical Trial Compass
TerminatedNot Applicable
Connected Catheter- Safety and Effectiveness Study
Stopped: The investigation of this device has been transitioned into a new study by the sponsor. The data generated in this study will not be used to support a marketing application
United States9 participantsStarted 2020-10-16
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. 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
✓. 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 criteria
✕. 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)
✕. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injections)
What they're measuring
1
Successful Bladder Emptying Using Connected Catheter
✕. 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)