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Test Catheter Pilot Study in Healthy Volunteers

NCT ID: NCT00832078

Last Updated: 2012-09-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2

Group Type OTHER

SpeediCath Compact Male

Intervention Type DEVICE

CH 12 hydrophilic coated intermitten compact catheter

Speedicath

Intervention Type DEVICE

CH 12 hydrophilic coated intermittent coated catheter

Group B

SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2

Group Type OTHER

SpeediCath Compact Male

Intervention Type DEVICE

CH 12 hydrophilic coated intermitten compact catheter

Speedicath

Intervention Type DEVICE

CH 12 hydrophilic coated intermittent coated catheter

Interventions

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SpeediCath Compact Male

CH 12 hydrophilic coated intermitten compact catheter

Intervention Type DEVICE

Speedicath

CH 12 hydrophilic coated intermittent coated catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* Male
* Signed informed consent
* Negative urine multistix

Exclusion Criteria

* Abnormalities, diseases or surgical procedures performed in the lower urinary tract
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Coloplast A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rigshopsitalet

Copenhagen, København Ø, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DK058CC

Identifier Type: -

Identifier Source: org_study_id