Safety and Performance of a New Coating for Urinary Intermittent Catheters
NCT ID: NCT01800903
Last Updated: 2020-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2013-02-28
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Sequence 1
SpeediCath catheter then ZN-D catheter then ZN-C catheter
ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Sequence 2
SpeediCath catheter then ZN-C catheter then ZN-D catheter
ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Sequence 3
ZN-D catheter then SpeediCath catheter then ZN-C catheter
ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Sequence 4
ZN-D catheter then ZN-C catheter then SpeediCath catheter
ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Sequence 5
ZN-C catheter then SpeediCath catheter then ZN-D catheter
ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Sequence 6
ZN-C catheter then ZN-D catheter then SpeediCath catheter
ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Interventions
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ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Eligibility Criteria
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Inclusion Criteria
2. Be at least 18 years of age and have full legal capacity
3. Be a male
4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
Exclusion Criteria
2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
3. Participating in other interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)
4. Known hypersensitivity toward any of the test products -
18 Years
MALE
Yes
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Per Bagi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, Rigshospitalet Denmark
Locations
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Department of Urology
Copenhagen, , Denmark
Countries
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Other Identifiers
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CP235
Identifier Type: OTHER
Identifier Source: secondary_id
CP235
Identifier Type: -
Identifier Source: org_study_id
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