Investigation of New Intermittent Catheters in Healthy Volunteers

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Coloplast

Status

Completed

Conditions

Retention, Urinary

Treatments

Device: SpeediCath® Standard male or female
Device: New intermittent Variant 2 catheter for male or female
Device: New intermittent Variant 1 catheter for male or female

Study type

Interventional

Funder types

Industry

Identifiers

NCT04445051
CP322

Details and patient eligibility

About

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

Full description

The CP322 study investigated a novel non-CE marked intermittent catheter for males and females, designed in two different variants, Variant 1 and Variant 2, respectively. The study was conducted in Denmark and was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 30 adult healthy volunteers. For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 30 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Minimum 18 years of age and with full legal capacity
  • Written informed consent and signed letter of authority and secrecy agreement given
  • Willing to comply with not using analgesics 1 up to 24 hours prior to catheterization visits
  • Urine Multistix negative for erythrocytes (hematuria)

Exclusion criteria

  • Participation in any other clinical investigations during this investigation
  • Known hypersensitivity towards any of the test products
  • Symptoms of urinary tract infection (UTI) (Investigators judgement)
  • Pregnancy or breastfeeding

Trial design

30 participants in 3 patient groups

Intermittent catheter; SpeediCath® Standard male or female
Active Comparator group
Description:
Participants underwent catheterization with standard of care intermittent catheter. The catheterization was performed by a trained nurse.
Treatment:
Device: SpeediCath® Standard male or female
New intermittent catheter Variant 1 for male or female
Experimental group
Description:
Participants underwent catheterization with the new intermittent catheter Variant 1 for males or females. The catheterization was performed by a trained nurse.
Treatment:
Device: New intermittent Variant 1 catheter for male or female
New intermittent catheter Variant 2 for male or female
Experimental group
Description:
Participants underwent catheterization with the new intermittent catheter Variant 2 for males or females. The catheterization was performed by a trained nurse.
Treatment:
Device: New intermittent Variant 2 catheter for male or female

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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