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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03626324
Other study ID # C2P-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 25, 2018
Est. completion date January 31, 2019

Study information

Verified date February 2019
Source Spinal Singularity
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date January 31, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Males age = 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction (NLUTD)

2. 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)

3. 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:

1. Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the device after Urinary Tract Infection (UTI) has been treated)

2. Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days)

3. Significant risk profile or recent history of clinically significant autonomic dysreflexia (AD) (e.g. History of hospitalization due to AD within past 12 months)

4. Significant intermittent urinary incontinence (between catheterizations)

5. Uninhibited bladder contractions and/or vesico-ureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injections)

6. 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)

7. Urinary tract inflammation or neoplasm

8. Urinary fistula

9. Bladder diverticulum (outpouching) > 5cm in size

10. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)

11. Impaired kidney function or renal failure

12. Active gross hematuria

13. Active urethritis

14. Bladder stones

15. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device

16. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications

17. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the C2P System

Study Design


Intervention

Device:
C2P
The C2P 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 C2P 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.

Locations

Country Name City State
United States 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 New Jersey Urology, 15000 Midlantic Drive, Suite 100 Mount Laurel New Jersey
United States Tri Valley Urology, 25495 Medical Center Dr., Suite 204 Murrieta California
United States Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104 Peoria Arizona
United States Northwest Urology Associates, 14674 W. Mountain View Blvd, Suite 210 Surprise Arizona
United States New Jersey Urology, 2401 Evesham Road, Suite F Voorhees New Jersey
United States Minnesota Urology, 6025 Lake Road Suite 200 Woodbury Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Spinal Singularity

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Freedom from genito-urinary injury/trauma Improved bladder management without injury to genito-urinary tract 3 months
Primary Successful Acute Performance- I To evaluate successful retention of C2P Day 0 (On the day of C2P insertion)
Primary Successful Acute Performance- II To evaluate successful bladder voiding with C2P Day 0 (On the day of C2P insertion)
Primary Successful Acute Performance- III To evaluate successful valve sealing of C2P Day 0 (On the day of C2P insertion)
Primary Successful Home-use Performance To evaluate successful home use of C2P using same measures as Acute Performance 3 months
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