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Investigation of New Intermittent Catheters in Healthy Volunteers

Investigation of New Intermittent Catheters in Healthy Volunteers

Recruiting
18 years and older
All
Phase N/A

Overview

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  1. Participation in any other clinical investigations during this investigation
  2. Known hypersensitivity towards any of the test products
  3. Symptoms of urinary tract infections (UTIs) (Investigators judgement)
  4. Pregnant or breastfeeding

Study details
    Urinary Retention

NCT04445051

Coloplast A/S

16 February 2024

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