Status:
COMPLETED
A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters
Lead Sponsor:
ConvaTec Inc.
Conditions:
Comfort and Performance of Intermittent Catheter
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the performance of GentleCath Glide™ Intermittent Catheters
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects of 18 years old and above who require intermittent bladder drainage may be recruited into the study
- Subjects must be willing and able to provide written informed consent
- Subjects may be either inpatients or outpatients but must all be capable of completing a patient diary card to record study data
- Subjects must currently use intermittent catheters and have been using intermittent catheters for the last six months
- Patients who self-catheterise at least three times per day
- Able to attend final assessment visit at day 14
- Exclusion Criteria
- Subjects who require intermittent catheterisation to administer irrigation or instillation.
- Subjects who are presently participating in another clinical trial.
- Subjects exhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study
- Subjects with known sensitivity to the device components
Exclusion
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2018
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03387878
Start Date
July 1 2017
End Date
January 10 2018
Last Update
December 6 2022
Active Locations (1)
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1
Specjalistyczny Gabinet Lekarski
Rzeszów, Poland, 35-326