Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658903
Recruitment Status : Unknown
Verified January 2016 by Oxys Medical AG.
Recruitment status was:  Recruiting
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Oxys Medical AG

Tracking Information
First Submitted Date  ICMJE November 20, 2015
First Posted Date  ICMJE January 20, 2016
Last Update Posted Date January 20, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study. [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
  • Significant bacteriuria assessed by weekly bacterial cultures. [ Time Frame: every week during 4 weeks ]
  • Clinically symptomatic catheter associated lower urinary infections. [ Time Frame: 4 weeks ]
  • occurence of adverse events [ Time Frame: within 4 weeks ]
    safety endpoint
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
Official Title  ICMJE Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
Brief Summary The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.
Detailed Description

This study is an open randomized controlled trial of 4 weeks duration. The intervention is a novel urinary catheter with an electromagnetic therapy to prevent catheter associated infections. The catheter is used in patients which require longterm urinary catheterization over at least 1 month.

The endpoint is bacteriological exam and the laboratory is blinded to the therapy status. Weekly urinary cultures are drawn and a sonication culture of the catheter tip is performed to detect and characterize the biofilm. A colonization rate of >95% is anticipated in the control arm. Therefore a 50% reduction in colonization can be detected with 54 patients, a 90% reduction in colonization can be detected with 20 patients with a power of 0.9.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Urinary Infections
Intervention  ICMJE
  • Device: Oxys Catheter
    The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy.
  • Device: Covidien Mona-Therm Foley catheter
    The control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien.
Study Arms  ICMJE
  • Experimental: Study arm with Oxys-Cathter
    The study group is treated with a modified urinary catheter, which delivers electromagnetic therapy to prevent and treat bacterial colonization during the study period. The intervention is the insertion of the study urinary catheter (foley) into the bladder.
    Intervention: Device: Oxys Catheter
  • Control-arm with commercial catheter
    The control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder,
    Intervention: Device: Covidien Mona-Therm Foley catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 19, 2016)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient with need for an indwelling urinary catheter to be placed at least for 4 weeks, which are willing and capable to provide informed consent. Most patients have spinal cord injury and are treated by the prinicpal investigator.

Exclusion Criteria:

  • Need for antibiotic treatment for any infections
  • Urological intervention or need for catheter change within study duration of 4 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02658903
Other Study ID Numbers  ICMJE Oxys-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oxys Medical AG
Study Sponsor  ICMJE Oxys Medical AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Kessler, MD Universitätsklinik Balgrist Zürich
PRS Account Oxys Medical AG
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP