Urinary InfectionsPhase 1NCT02658903
Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
A Phase 1 study testing Oxys Catheter and Covidien Mona-Therm Foley catheter in people with Urinary Infections, run by Oxys Medical AG at 1 site in Switzerland.
Trial summary
The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Infections
- What is being tested?
- Oxys Catheter and Covidien Mona-Therm Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2016to Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Need for antibiotic treatment for any infections
- Urological intervention or need for catheter change within study duration of 4 weeks
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Balgrist
Zurich, Canton of Zurich, 8008
Thomas Kessler, Prof., MD, 0041 44 386 11 11, Thomas.Kessler@balgrist.ch
Ulrich Menert, MD, 0041 44 386 56 68, Ulrich.Mehnert@balgrist.ch
About this study
The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.
Read the 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.
- Conditions
- Urinary Infections
- Being tested
- Oxys Catheter, Covidien Mona-Therm Foley catheter
- Keywords
- Foley, Infection, Hospital acquired, catheter associated, urinary
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxys CatheterDevice
The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy.
Covidien Mona-Therm Foley catheterDevice
The control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien.
| Study group | Role | What they receive |
|---|---|---|
| Study arm with Oxys-Cathter | Experimental | 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. Receives: Device: Oxys Catheter |
| Control-arm with commercial catheter | Other | The control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder, Receives: Device: Covidien Mona-Therm Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.
Measured: 4 weeks
Secondary outcomes (3)
Significant bacteriuria assessed by weekly bacterial cultures.
Measured: every week during 4 weeks
Clinically symptomatic catheter associated lower urinary infections.
Measured: 4 weeks
occurence of adverse events
safety endpoint
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxys Medical AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Kessler, MD, Principal investigator, Universitätsklinik Balgrist Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658903
- Sponsor's protocol ID
- Oxys-01
- Status last verified
- Jan 2016
- First submitted
- 20 Nov 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
- ClinicalTrials.gov ID
- NCT02658903
- Acronym / sponsor ID
- Oxys-01
- Conditions
- Urinary Infections
- Keywords
- Foley, Infection, Hospital acquired, catheter associated, urinary
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Oxys Medical AGUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm with Oxys-Cathter | Experimental | Device: Oxys CatheterThe 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 | Other | Device: Covidien Mona-Therm Foley catheterThe control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Need for antibiotic treatment for any infections
- Urological intervention or need for catheter change within study duration of 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxys CatheterThe study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy. | Device | Study arm with Oxys-Cathter |
| Covidien Mona-Therm Foley catheterThe control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien. | Device | Control-arm with commercial catheter |
Primary outcome
Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.
Time frame: 4 weeks
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kessler, MD principal investigator
Universitätsklinik Balgrist Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxys Catheter and Covidien Mona-Therm Foley catheter in people with Urinary Infections, run by Oxys Medical AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Scharf, MD (++41763322969, christoph.scharf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.