Connected Catheter Clinical Feasibility Study( CFS)

NCT03405285 | Completed

• 1 other identifier: CoCath-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to evaluate the safety and essential performance of the Connected Catheter System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting, and during and extended period (up to 29 days) of home use.

Conditions

Urinary Bladder, Neurogenic

Keywords

Improved Bladder Management; Neurogenic Lower Urinary Tract Dysfunction; Bladder function following Spinal Cord Injury; Urinary Retention

Outcome Measures

Primary Outcomes (6)

• Freedom from genito-urinary injury/trauma

  Improved bladder management without injury or trauma to genito-urinary tract

  29 Days

• Successful Acute Performance- I

  To evaluate successful retention of Connected Catheter and Void

  On the day of Connected Catheter Insertion

• Successful Acute Performance -II

  To evaluate successful bladder voiding with Connected Catheter

  On the day of Connected Catheter Insertion

• Successful Acute Performance- III

  To evaluate successful removal of Connected Catheter

  On the day of Connected Catheter Insertion

• Successful Acute Performance- IV

  To evaluate successful post-void sealing of Connected Catheter Valve

  On the day of Connected Catheter Insertion

• Successful Home-Use Performance

  Successful Home-Use using same measures as Acute Performance

  29 days

Study Arms (1)

Connected Catheter Feasibility Study

EXPERIMENTAL

Clinical Feasibility Evaluation of Connected Catheter Wireless Urinary Prosthesis for Management of Neurogenic Lower Urinary Tract Dysfunction

Device: Connected Catheter

Interventions

Connected Catheter DEVICE

The Connected Catheter 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 CoCath 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.

Connected Catheter Feasibility Study

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 strategy Must have stable urinary management history with clean intermittent catheterization: no significant changes in bladder management regimen within past 12 months
• OR:
• Must have urodynamic profile suitable for CIC, as assessed via urodynamics study within past 12 months (including bladder capacity \> 200mL without uninhibited bladder contractions)
• Subject's lower urinary tract anatomy (lengths of proximal and distal urethral must fall within the ranges serviceable by the Connected Catheter device, as specified in the investigational device instructions for use.
• For cases of NLUTD due to spinal cord injury, the subject must be in medically stable condition (i.e. post-spinal shock phase)

You may not qualify if:

• Active symptomatic urinary tract infection, as defined in this protocol (subjects may receive the CoCath 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 autonomic dysreflexia (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, urine analysis, and blood labs)
• 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 (assessed via blood creatinine levels \> 2 mg/dL)
• 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

Sponsors & Collaborators

• Spinal Singularity: lead

Study Sites (2)

West Coast Urology, 11411 Brookshire Avenue, Suite 508

Downey, California, 90241, United States

Location

Tri Valley Urology, 25495 Medical Center Dr., Suite 204

Murrieta, California, 92562, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Urinary Retention

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 23, 2018
• Study Start: February 28, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: September 26, 2018

Record last verified: 2018-07

Locations

US (2)