Investigation of New Intermittent Catheters in Healthy Volunteers

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Coloplast A/S
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Updated on 19 February 2024
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Summary

Investigation of non-CE marked intermittent catheters. The study is a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.

Description

The CP322 study is an investigation of non-CE marked intermittent catheters which will be conducted in Denmark. The study is a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.

Details
Condition Urinary Retention
Age 18years - 100years
Treatment New intermittent catheters variation 1 and 2 for both male and females
Clinical Study IdentifierNCT04445051
SponsorColoplast A/S
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is at least 18 years of age and has full legal capacity
Has given written informed consent and signed letter of authority and secrecy agreement
Willing to comply with not using analgesics1 up to 24 hours prior to catheterisation visits
Negative urine multistix - erythrocytes (haematuria)

Exclusion Criteria

Participation in any other clinical investigations during this investigation
Known hypersensitivity towards any of the test products
Symptoms of urinary tract infections (UTIs) (Investigators judgement)
Pregnant or breastfeeding
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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