- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05330598
Evaluation of the Safety and Clinical Performance of the Connected Catheter Study
Evaluation of the Safety and Clinical Performance of the Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
The objective of this study is to evaluate the safety and effectiveness of the Connected Catheter in males with chronic Urinary Retention, both in a clinical setting and an extended period of home use.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Downey, California, United States, 90242
- Rancho Research Institute
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Inglewood, California, United States, 90301
- West Coast Urology, 575 E. Hardy St., Suite 215
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Murrieta, California, United States, 92562
- Tri Valley Urology, 25495 Medical Center Dr., Suite 204
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San Diego, California, United States, 92103
- UCSD
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District of Columbia
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Washington, District of Columbia, United States, 20010
- MedStar National Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. Males > 22 years old diagnosed with chronic Urinary Retention 2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling catheter strategy:
- Must have stable urinary management history as determined by the Principal Investigator OR
- Must have urodynamic profile suitable for the 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 Connected Catheter device, as specified in the Investigational Device Instructions For Use.
Exclusion Criteria:
1. Active symptomatic urinary tract infection, as defined in this clinical investigation plan (CIP)/protocol (subjects may receive the device after their 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 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 injection)
- Active symptomatic urinary tract infection, as defined in this clinical investigation plan (CIP)/protocol (subjects may receive the device after their 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
- Significant intermittent urinary incontinence (between catheterizations)
- Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g., Botox injection)
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 Principal 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
- Vulnerable population such as inmates or developmentally delayed adults
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Connected Catheter Users
Device: Connected Urinary Catheter Patients will use the Connected Catheter to empty the bladder during the course of treatment.
|
The Connected Catheter System is a replaceable wireless urinary prosthesis that is indicated for bladder emptying in male patients who have impaired bladder emptying due to chronic Urinary Retention.
The Connected Catheter resides fully internally in the male lower urinary tract (urethra and bladder neck) and remains in place for up to 7 days before removal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful Bladder Emptying Using Connected Catheter
Time Frame: 4 weeks
|
PVR Responder Rate, defined as either:
The subject responder rate, R, is estimated as the proportion of subjects who are classified as responders. |
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIP-0003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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