Connected Catheter (C2P) Study for Bladder Management

S

Spinal Singularity

Status

Completed

Conditions

Urinary Retention
Neurogenic Bladder

Treatments

Device: C2P

Study type

Interventional

Funder types

Industry

Identifiers

NCT03626324
C2P-01

Details and patient eligibility

About

The objective of this study is to evaluate the safety and essential performance of the C2P System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting and an extended period of home use.

Full description

Spinal Singularity had developed C2P system to address several drawbacks of current standard-of-care urinary catheters. The C2P is fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization, including NLUTD. The C2P is a sterile, single-extended use device that resides fully internally to the male lower urinary tract for an intended service life of up to 29 days per catheter

Enrollment

27 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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 C2P, as assessed via urodynamics study within past 12 months (including bladder capacity > 200mL without uninhibited bladder contractions)
  • Subject's lower urinary tract anatomy must fall within the ranges serviceable by the C2P device, as specified in the investigational device instructions for use (IFU).

Exclusion criteria

  • Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the device after Urinary Tract Infection (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 (AD) (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 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 C2P System

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

27 participants in 1 patient group

C2P Study
Experimental group
Description:
Clinical Evaluation of Connected Catheter 2P Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction
Treatment:
Device: C2P

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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