Safety and Performance of a New Coating for Urinary Intermittent Catheters
Clinical Study Investigating Safety and Performance of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers
1 other identifier
interventional
40
1 country
1
Brief Summary
The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 22, 2013
CompletedFirst Posted
Study publicly available on registry
February 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
March 14, 2014
CompletedSeptember 10, 2020
August 1, 2020
2 months
February 22, 2013
November 29, 2013
August 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Discomfort During Catheterization
Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.
1 day
Study Arms (6)
Sequence 1
ACTIVE COMPARATORSpeediCath catheter then ZN-D catheter then ZN-C catheter
Sequence 2
EXPERIMENTALSpeediCath catheter then ZN-C catheter then ZN-D catheter
Sequence 3
EXPERIMENTALZN-D catheter then SpeediCath catheter then ZN-C catheter
Sequence 4
EXPERIMENTALZN-D catheter then ZN-C catheter then SpeediCath catheter
Sequence 5
EXPERIMENTALZN-C catheter then SpeediCath catheter then ZN-D catheter
Sequence 6
EXPERIMENTALZN-C catheter then ZN-D catheter then SpeediCath catheter
Interventions
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
The Speedicath cathere is CE-marked and commercially available.
Eligibility Criteria
You may qualify if:
- Have given written informed consent and signed letter of authority
- Be at least 18 years of age and have full legal capacity
- Be a male
- Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
You may not qualify if:
- Abnormalities, diseases or surgical procedures performed in the lower urinary tract
- Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
- Known hypersensitivity toward any of the test products -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (1)
Department of Urology
Copenhagen, 2100, Denmark
Results Point of Contact
- Title
- Trine Møller Senior Clinical Manager
- Organization
- Coloplast A/S
Study Officials
- PRINCIPAL INVESTIGATOR
Per Bagi, MD, PhD
Department of Urology, Rigshospitalet Denmark
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2013
First Posted
February 28, 2013
Study Start
February 1, 2013
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
September 10, 2020
Results First Posted
March 14, 2014
Record last verified: 2020-08