Status:
COMPLETED
Evaluation of Safety and Tolerability of Nitric Oxide Impregnated Urinary Catheters
Lead Sponsor:
Enox Israel Ltd
Collaborating Sponsors:
Rabin Medical Center
Conditions:
Urinary Tract Infection
Bacteriuria
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
According to the World Health Organization, hundreds of millions of patients are affected by health-care associated infections worldwide each year, resulting in prolonged hospital stays, long-term dis...
Eligibility Criteria
Inclusion
- Patients before radical prostatectomy at the Department of Urology in Beilinson Medical Center, which will be catheterized for 7-14 days.
- Age: ≥ 18 years.
- Patients with a life expectancy of more than 12 months.
- The investigator has completed a medical history and a physical examination to assure that the patients meets all study enrollment criteria.
- The patient is willing and able to read, understand and sign the study specific informed consent form.
Exclusion
- A urinary culture demonstrating UTI before surgery.
- A patient with an indwelling urinary catheter prior to surgery.
- Expected life expectancy of less than 12 months.
- Concurrent illness, disability or geographical residence that would hamper study participation.
- Patients with underlying diseases such as heart disease, lung disease, skin disease or infection involving the penis, scrotum and groin, immunocompromised patients (transplant recipients, HIV carriers) or any other disease or condition that according to the physician opinion will influence the study results.
- Patients with known urethral stricture.
- Patients with recurrent UTIs.
- Current participation in another clinical investigation of a medical device or a drug or has participated in such a study within 30 days prior to study enrollment.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02277171
Start Date
December 1 2014
End Date
September 1 2015
Last Update
December 24 2015
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