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Evaluation of the Safety and Clinical Performance of the Connected Catheter Study

Primary Purpose

Urinary Retention, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Connected Catheter
Sponsored by
Spinal Singularity
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention focused on measuring Intermittent Catheter, Intermittent catheterization, Urinary retention, Impaired bladder

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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:

    1. Must have stable urinary management history as determined by the Principal Investigator OR
    2. 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)

    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)
    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 Principal 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
    11. Vulnerable population such as inmates or developmentally delayed adults

Sites / Locations

  • Rancho Research InstituteRecruiting
  • West Coast Urology, 575 E. Hardy St., Suite 215Recruiting
  • Tri Valley Urology, 25495 Medical Center Dr., Suite 204Recruiting
  • UCSDRecruiting
  • Medstar National Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Connected Catheter Users

Arm Description

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

Outcomes

Primary Outcome Measures

Successful Bladder Emptying Using Connected Catheter
PVR Responder Rate, defined as either: Less than or equal to 50mL OR Equal to or less than their baseline PVR when using SOC catheters The subject responder rate, R, is estimated as the proportion of subjects who are classified as responders.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2022
Last Updated
August 22, 2023
Sponsor
Spinal Singularity
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1. Study Identification

Unique Protocol Identification Number
NCT05330598
Brief Title
Evaluation of the Safety and Clinical Performance of the Connected Catheter Study
Official Title
Evaluation of the Safety and Clinical Performance of the Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

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
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
UroDev Medical 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 4 weeks including weekly device exchange appointments. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Chronic
Keywords
Intermittent Catheter, Intermittent catheterization, Urinary retention, Impaired bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multicenter, single arm trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Connected Catheter Users
Arm Type
Experimental
Arm Description
Device: Connected Urinary Catheter Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Intervention Type
Device
Intervention Name(s)
Connected Catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful Bladder Emptying Using Connected Catheter
Description
PVR Responder Rate, defined as either: Less than or equal to 50mL OR Equal to or less than their baseline PVR when using SOC catheters The subject responder rate, R, is estimated as the proportion of subjects who are classified as responders.
Time Frame
4 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
The connected catheter is designed for male use.
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Messer
Phone
7636577036
Email
clinical@urodevmedical.com
Facility Information:
Facility Name
Rancho Research Institute
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Avina
Email
savina@ranchoresearch.org
First Name & Middle Initial & Last Name & Degree
Evgeniy Kreydin, MD
Facility Name
West Coast Urology, 575 E. Hardy St., Suite 215
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imma Villamor
Email
imma.villamor@uniohp.com
First Name & Middle Initial & Last Name & Degree
Ernest Agatstein, MD
Facility Name
Tri Valley Urology, 25495 Medical Center Dr., Suite 204
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Deeds
Phone
951-698-1901
Ext
232
Email
anita@trivalleyurology.com
First Name & Middle Initial & Last Name & Degree
Sreenivas Vemulapalli, MD
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trisha Kanie
Email
tkanie@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Yahir Santiago-Lasatra, MD
Facility Name
Medstar National Rehabilitation Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Rounds
Email
amanda.k.rounds@medstar.net
First Name & Middle Initial & Last Name & Degree
Suzanne Groah, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Safety and Clinical Performance of the Connected Catheter Study

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