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Connected Catheter- Safety and Effectiveness Study

NCT ID: NCT03843073

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-16

Study Completion Date

2021-04-06

Brief Summary

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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.

Detailed Description

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Spinal Singularity has developed the Connected Catheter System to address several drawbacks of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. Each subject will use the Connected Catheter for up to 35-40 days. This includes five device exchange appointments. The appointments are spaced 7 days apart and at each appointment the catheter will be replaced with a new one. Additionally, weekly follow-up will occur for 14 days following the final appointment after the subject discontinues use of study device and reverts to his original catheter.

Conditions

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Urinary Retention Neurogenic Bladder Urologic Diseases

Keywords

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Spinal Cord Injury (SCI), Neurogenic Lower Urinary Tract Dysfunction (NLUTD) Catheter associated Urinary Tract Infection (CAUTI) Urinary Catheters Urinary Retention Enlarged Prostate Prostate cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Connected Catheter Users

Group Type EXPERIMENTAL

Connected Urinary Catheter

Intervention Type DEVICE

Patients will use the Connected Catheter to empty the bladder during the course of treatment.

Interventions

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Connected Urinary Catheter

Patients will use the Connected Catheter to empty the bladder during the course of treatment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Males age ≥ 18 with clinical diagnosis of significant urinary retention
2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy

Must have stable urinary management history as determined by the Investigator

OR:

Must have urodynamic profile suitable for the Gen 2 Connected Catheter (including bladder capacity \> 200mL without uninhibited bladder contractions)
3. 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

1. Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the device after 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 (uncontrolled) autonomic dysreflexia (AD)
4. Significant intermittent urinary incontinence (between catheterizations)
5. Uninhibited bladder contractions and/or Vesicoureteral 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)

1. Urinary tract inflammation or neoplasm
2. Urinary fistula
3. Bladder diverticulum (outpouching) \> 5cm in size
4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)
5. Impaired kidney function or renal failure
6. Active gross hematuria
7. Active urethritis
8. Bladder stones
7. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device
8. Any unsuitable comorbidities as determined by the investigator or complications related to use of certain medications
9. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Connected Catheter System
10. Catheter Assessment Tool screening yields unacceptable results
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Spinal Singularity

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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West Coast Urology, 11411 Brookshire Avenue, Suite 508

Downey, California, United States

Site Status

West Coast Urology, 575 E. Hardy St., Suite 215

Inglewood, California, United States

Site Status

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

Murrieta, California, United States

Site Status

Chesapeake Urology

Owings Mills, Maryland, United States

Site Status

Minnesota Urology, 6025 Lake Road Suite 200

Woodbury, Minnesota, United States

Site Status

New Jersey Urology, 15000 Midlantic Drive, Suite 100

Mount Laurel, New Jersey, United States

Site Status

New Jersey Urology, 2401 Evesham Road, Suite F

Voorhees Township, New Jersey, United States

Site Status

Dr. Jonathan Vapnek Urology

New York, New York, United States

Site Status

Urology San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CIP-0001 (Formerly ES-01)

Identifier Type: -

Identifier Source: org_study_id