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Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04059159
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Spinal Singularity

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.

Condition or disease Intervention/treatment Phase
Neurogenic Bladder Urinary Retention Urologic Diseases Device: Connected Catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
Experimental: Connected Catheter Users Device: Connected Catheter
Patients will use the Connected Catheter to empty the bladder during the course of treatment.




Primary Outcome Measures :
  1. Post-void residual urine volume (PVR) with the use of the Connected Catheter [ Time Frame: 35 - 40 days ]

    Rate of participants with successful voiding using the Connected Catheter as assessed by Post-Residual Volume (PVR) measurement via ultrasound

    A subject is considered a responder to the treatment if a minimum of 80% of their PVR values met the following criteria

    PVR is ≤ 50 mL OR PVR is ≤ baseline PVR with the standard of care catheter


  2. Rate of device related Serious Adverse Events [ Time Frame: 0 - 40 days ]
    Rate of participants treated with the Connected Catheter reported with a serious device related adverse event


Secondary Outcome Measures :
  1. Successful device insertion, anchoring, and removal [ Time Frame: 35 - 40 days ]
    Rate of Connected Catheter successfully inserted, anchored and removed

  2. Successful sealing of the catheter valve [ Time Frame: 35 - 40 days ]
    Rate of Connected Catheter valves sealed successfully

  3. Quality of life improvement as measured by SCI-QOL Survey [ Time Frame: 35 - 40 days ]
    Rate of participants treated with the Connected Catheter with improved overall quality of life as measured by the SCI-QOL Survey

  4. UTI occurrence rate [ Time Frame: 35 - 40 days ]
    Rate of participants treated with the Connected Catheter reported with a urinary tract infection

  5. Lower Urinary Tract injury rate [ Time Frame: 35 - 40 days ]
    Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Device is currently only designed for use by males.
Accepts Healthy Volunteers:   No
Criteria

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

    1. Must have stable urinary management history as determined by the investigator OR:
    2. Must have urodynamic profile suitable for 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, as defined in this clinical investigation 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
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059159


Contacts
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Contact: Shannon Metzger 949-436-7974 shannon@spinalsingularity.com

Locations
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United States, California
Rancho Los Amigos Rehabiliation Hospital Recruiting
Downey, California, United States, 90242
Contact: Sandra Avina    562-385-7048    savina@ranchoresearch.org   
Principal Investigator: Evgeniy Kreydin, MD         
Principal Investigator: David Ginsberg, MD         
UC San Diego Not yet recruiting
San Diego, California, United States, 92093
Contact: Archana Bhatt    858-822-2661    abhatt@ucsd.edu   
Principal Investigator: Michael Albo, MD         
Principal Investigator: Yahir Santiago-Lastra, MD         
United States, District of Columbia
MedStar National Rehabilitation Hospital Recruiting
Washington, District of Columbia, United States, 20010
Contact: Amanda Rounds    202-877-1694    Amanda.K.Rounds@medstar.net   
Principal Investigator: Suzanne Groah, MD         
Principal Investigator: Krishnan Venkatesan, MD         
Sponsors and Collaborators
Spinal Singularity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Responsible Party: Spinal Singularity
ClinicalTrials.gov Identifier: NCT04059159    
Other Study ID Numbers: CIP-0002 (formerly ES-NIH-01)
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Spinal Singularity:
catheter
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Urinary Retention
Urologic Diseases
Urination Disorders
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases