Study Stopped
Product development project closed prematurely
Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
1 other identifier
interventional
N/A
1 country
1
Brief Summary
To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2011
CompletedFirst Posted
Study publicly available on registry
February 10, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedAugust 7, 2015
August 1, 2015
3 months
February 9, 2011
August 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Discomfort during catheterisation measured by VAS-scale (0-10)
A subject is assesing a VAS scale after each catheterisation.
10 measurements in an 11 week period. 10 min after each catheterisation
Secondary Outcomes (4)
Safety
During the investigation 11 Weeks per subject
Discomfort during urination post catheterisation
10 measurements in an 11 week period. 10 min after each catheterisation
Haematuria
10 measurements in an 11 week period. 10 min after each catheterisation
Handling during insertion, withdrawal
10 measurements in an 11 week period. 10 min after each catheterisation
Study Arms (4)
Active comparator/Yellow catheter
ACTIVE COMPARATORSpeediCath coated catheter
NonCE marked intermittent catheter/red
EXPERIMENTALNonCE marked intermittent catheter/green
EXPERIMENTALNonCE marked intermittent catheter/Blue
EXPERIMENTALInterventions
Speedicath, Intermittent catheterisation
Paris, Intermittent catheterisation
Paris, Intermittent catheter
Paris, Intermittent catheter
Eligibility Criteria
You may qualify if:
- ≥18 years
- Male
- Signed informed consent
- Negative urine stix (erythrocytes, leucocytes and nitrite)
You may not qualify if:
- Abnormalities, diseases or surgical procedures performed in the lower urinary tract
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Susanne Gürtler, CTM
Coloplast A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 9, 2011
First Posted
February 10, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 7, 2015
Record last verified: 2015-08