NCT04445051

Investigation of New Intermittent Catheters in Healthy Volunteers

Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Retention, Urinary

Interventions

Type	Name	Description
DEVICE	SpeediCath® Standard male or female	Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female.
DEVICE	New intermittent Variant 1 catheter for male or female	Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.
DEVICE	New intermittent Variant 2 catheter for male or female	Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2020-06-24
• Last updated: 2023-07-03
• Results posted: 2023-07-03

Locations

1 site across 1 country: Denmark