Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
1 other identifier
interventional
54
1 country
1
Brief Summary
The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedFirst Posted
Study publicly available on registry
January 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJanuary 20, 2016
January 1, 2016
1 year
November 20, 2015
January 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.
4 weeks
Secondary Outcomes (3)
Significant bacteriuria assessed by weekly bacterial cultures.
every week during 4 weeks
Clinically symptomatic catheter associated lower urinary infections.
4 weeks
occurence of adverse events
within 4 weeks
Study Arms (2)
Study arm with Oxys-Cathter
EXPERIMENTALThe 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.
Control-arm with commercial catheter
OTHERThe control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder,
Interventions
The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy.
The control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Need for antibiotic treatment for any infections
- Urological intervention or need for catheter change within study duration of 4 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oxys Medical AGlead
Study Sites (1)
University Hospital Balgrist
Zurich, Canton of Zurich, 8008, Switzerland
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Kessler, MD
Universitätsklinik Balgrist Zürich
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2015
First Posted
January 20, 2016
Study Start
January 1, 2016
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
January 20, 2016
Record last verified: 2016-01