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Connected Catheter Clinical Feasibility Study( CFS)

Primary Purpose

Urinary Bladder, Neurogenic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Connected Catheter

About this trial

This is an interventional supportive care trial for Urinary Bladder, Neurogenic focused on measuring Improved Bladder Management, Neurogenic Lower Urinary Tract Dysfunction, Bladder function following Spinal Cord Injury, Urinary Retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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 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)

Exclusion Criteria:

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
Individuals allergic or otherwise unable to take oral antibiotics
Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the CoCath System

Sites / Locations

West Coast Urology, 11411 Brookshire Avenue, Suite 508
Tri Valley Urology, 25495 Medical Center Dr., Suite 204

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Connected Catheter Feasibility Study

Arm Description

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

Outcomes

Primary Outcome Measures

Freedom from genito-urinary injury/trauma

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

Successful Acute Performance- I

To evaluate successful retention of Connected Catheter and Void

Successful Acute Performance -II

To evaluate successful bladder voiding with Connected Catheter

Successful Acute Performance- III

To evaluate successful removal of Connected Catheter

Successful Acute Performance- IV

To evaluate successful post-void sealing of Connected Catheter Valve

Successful Home-Use Performance

Successful Home-Use using same measures as Acute Performance

Secondary Outcome Measures

Full Information

NCT ID

NCT03405285

First Posted

January 9, 2018

Last Updated

September 24, 2018

Sponsor

Spinal Singularity

1. Study Identification

Unique Protocol Identification Number

NCT03405285

Brief Title

Connected Catheter Clinical Feasibility Study( CFS)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

February 28, 2018 (Actual)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Spinal Singularity

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The Connected Catheter (C2P) is a replaceable urinary prosthesis that is intended for use in male patients 18 years of age or older who have impaired bladder emptying due to neurogenic lower urinary tract dysfunction, and who are capable of operating the device in accordance with the provided instructions for use, or who have trained caregivers capable of doing the same. The device must be replaced every 29 days

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Bladder, Neurogenic

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Connected Catheter Feasibility Study

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Connected Catheter

Intervention Description

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.

Primary Outcome Measure Information:

Title

Freedom from genito-urinary injury/trauma

Description

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

Time Frame

29 Days

Title

Successful Acute Performance- I

Description

To evaluate successful retention of Connected Catheter and Void

Time Frame

On the day of Connected Catheter Insertion

Title

Successful Acute Performance -II

Description

To evaluate successful bladder voiding with Connected Catheter

Time Frame

On the day of Connected Catheter Insertion

Title

Successful Acute Performance- III

Description

To evaluate successful removal of Connected Catheter

Time Frame

On the day of Connected Catheter Insertion

Title

Successful Acute Performance- IV

Description

To evaluate successful post-void sealing of Connected Catheter Valve

Time Frame

On the day of Connected Catheter Insertion

Title

Successful Home-Use Performance

Description

Successful Home-Use using same measures as Acute Performance

Time Frame

29 days

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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) Exclusion Criteria: 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 Individuals allergic or otherwise unable to take oral antibiotics Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the CoCath System

Facility Information:

Facility Name

West Coast Urology, 11411 Brookshire Avenue, Suite 508

City

Downey

State/Province

California

ZIP/Postal Code

90241

Country

United States

Facility Name

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

City

Murrieta

State/Province

California

ZIP/Postal Code

92562

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Connected Catheter Clinical Feasibility Study( CFS)

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