Back to resultsConnected Catheter - Safety and Effectiveness Study
Primary Purpose
Neurogenic Bladder, Urinary Retention, Urologic Diseases
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Connected Catheter
Sponsored by
About this trial
This is an interventional supportive care trial for Neurogenic Bladder focused on measuring catheter, Spinal Cord Injury (SCI)
Eligibility Criteria
Inclusion Criteria:
- 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 as determined by the investigator OR:
- Must have urodynamic profile suitable for Gen 2 Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions)
- 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:
- Active symptomatic urinary tract infection, as defined in this clinical investigation 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
- 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
- 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 Gen 2 Connected Catheter System
- Catheter Assessment Tool screening yields unacceptable results
Sites / Locations
- Rancho Los Amigos Rehabiliation Hospital
- UC San Diego
- MedStar National Rehabilitation Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Connected Catheter Users
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Device Related Serious Adverse Events
Rate of participants treated with the Connected Catheter reported with a serious device related adverse event
Secondary Outcome Measures
Number of Participants With UTI (Occurrence Rate)
Rate of participants treated with the Connected Catheter reported with a symptomatic urinary tract infection
Number of Participants With Lower Urinary Tract Injury
Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury
Full Information
NCT ID
NCT04059159
First Posted
August 14, 2019
Last Updated
December 28, 2022
Sponsor
Spinal Singularity
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04059159
Brief Title
Connected Catheter - Safety and Effectiveness Study
Official Title
Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
The investigation of this device has been transitioned into a new study by the sponsor. The data generated in this study will not be used to support a marketing application
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 24, 2021 (Actual)
Study Completion Date
April 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spinal Singularity
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder, Urinary Retention, Urologic Diseases
Keywords
catheter, Spinal Cord Injury (SCI)
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
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Connected Catheter Users
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Connected Catheter
Intervention Description
Patients will use the Connected Catheter to empty the bladder during the course of treatment.
Primary Outcome Measure Information:
Title
Number of Participants With Device Related Serious Adverse Events
Description
Rate of participants treated with the Connected Catheter reported with a serious device related adverse event
Time Frame
0 - 49 days
Secondary Outcome Measure Information:
Title
Number of Participants With UTI (Occurrence Rate)
Description
Rate of participants treated with the Connected Catheter reported with a symptomatic urinary tract infection
Time Frame
0 - 49 days
Title
Number of Participants With Lower Urinary Tract Injury
Description
Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury
Time Frame
0 - 40 days
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Device is currently only designed for use by males.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 as determined by the investigator OR:
Must have urodynamic profile suitable for Gen 2 Connected Catheter (including bladder capacity > 200mL without uninhibited bladder contractions)
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:
Active symptomatic urinary tract infection, as defined in this clinical investigation 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
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
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 Gen 2 Connected Catheter System
Catheter Assessment Tool screening yields unacceptable results
Facility Information:
Facility Name
Rancho Los Amigos Rehabiliation Hospital
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
UC San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
MedStar National Rehabilitation Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Connected Catheter - Safety and Effectiveness Study
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