Status:
COMPLETED
Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Urinary Catheters
Lead Sponsor:
Region Skane
Collaborating Sponsors:
Lund University
Vinnova
Conditions:
Urinary Catheters
Retention, Urinary
Eligibility:
MALE
Phase:
NA
Brief Summary
A randomized, open label, controlled, parallel group study to investigate difference between regional standard procedure and a novel modified procedure (using an additional novel device to facilitate ...
Detailed Description
This is a randomized, open label, controlled, parallel group study, which comprises one visit that includes: assessment for eligibility, randomization to one of two treatment alternatives, followed by...
Eligibility Criteria
Inclusion
- The patient has an indwelling catheter and a primary diagnosis that justify continued catheter use
- The patient provides informed consent prior to any study specific procedures
- The patient is considered to benefit from participation in the clinical study
Exclusion
- The patient do not consent to participate in the study
- Trauma to urethra or bladder
- Infection to urethra or bladder
- Other diagnosis that contraindicates participation in the clinical study as judged by the responsible physician
Key Trial Info
Start Date :
April 17 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03289117
Start Date
April 17 2016
End Date
May 26 2017
Last Update
October 20 2017
Active Locations (1)
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1
Skåne University Hospital - Urology clinic - Homecare unit
Lund, Sweden, 22185