Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
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|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
|Condition or disease||Intervention/treatment||Phase|
|Urinary Infections||Device: Oxys Catheter Device: Covidien Mona-Therm Foley catheter||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2017|
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.
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.
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,
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.
- Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study. [ Time Frame: 4 weeks ]
- 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
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): NCT02658903
|Contact: Christoph Scharf, MDfirstname.lastname@example.org|
|Contact: Christine Tivig, MD||+41 email@example.com|
|Principal Investigator:||Thomas Kessler, MD||Universitätsklinik Balgrist Zürich|