Connected Catheter- Evaluation Study

  • STATUS
    Recruiting
  • End date
    Mar 30, 2021
  • participants needed
    80
  • sponsor
    Spinal Singularity
Updated on 30 July 2020

Summary

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.

Description

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.

Details
Treatment Connected Urinary Catheter
Clinical Study IdentifierNCT03843073
SponsorSpinal Singularity
Last Modified on30 July 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 90 yrs?
Are you male?
Do you have any of these conditions: Urinary Retention or Chronic Urinary Retention or URINARY TRACT DISORDER or bladder disorder or Neurogenic Bladder or Bladder Disorders?
Males age 18 with clinical diagnosis of significant urinary retention
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 Connected Catheter (including
bladder capacity > 200mL without uninhibited bladder contractions)
\. Subject's lower urinary tract anatomy must fall within the ranges
serviceable by the Connected Catheter, as specified in the Investigational
Device Instructions for use (IFU)

Exclusion Criteria

Active symptomatic urinary tract infection (UTI), as defined in this protocol (subjects may receive the 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 (uncontrolled) autonomic dysreflexia (AD)
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 Connected Catheter System
Catheter Assessment Tool screening yields unacceptable results
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in .
Loading...

No made yet