NCT04231149

Explorative Clinical Study on the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers

Explorative Clinical Study Investigating the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Performance and acceptance of new intermittent catheters tested in healthy volunteers

Detailed description

This study is a single blinded, randomised, crossover study. The study period consists of an information visit, an inclusion visit, three test visits and a termination visit. Two prototypes of intermittent catheters (Test product 2 and 3) compared to the standard catheter SpeediCath® Flex (Comparator). In the investigation ten subjects will be included. The subjects will be catheterised once per visit. The subjects will be catheterised with the two test catheters and comparator in a randomised order. The order of the catheterisations will be randomised to prevent bias. During the test visits the primary, secondary and explorative endpoints will be registered. Subjects will be asked to participate in an interview in continuation of their last visit (Test Visit 3). The interviews will be performed by a Coloplast representative asking questions related to their experience with the catheter. The subjects must sign a separate consent form for this purpose and can participate in the investigation without participating in the interview. In addition, subjects will be asked for consent to tape recording and filming during the interviews, but can participate in interviews without this. In addition, a Coloplast representative will interview the Investigator and her representatives after LPO with questions related to their experience with the catheters. The investigation is planned to be conducted in August 2018-Januar 2019. The visit window will be minimum five days between the visits (catheterisations), to ensure time for healing of any potential urethral trauma. However, the maximum time between visits should be adjusted to ensure the subject is terminated before LPO. No biobank will be established for this investigation. All urine samples in the clinical investigation (for evaluating in- and exclusion criteria and for evaluating end points) will be destructed immediately after analysis.

Conditions

• Compliance, Patient

Interventions

Type	Name	Description
DEVICE	Test product 2	Test catheter 2
DEVICE	Test product 3	Test catheter 3
DEVICE	Comparator	SpeediCath Flex

Timeline

• Start date: 2018-11-05
• Primary completion: 2018-12-20
• Completion: 2018-12-20
• First posted: 2020-01-18
• Last updated: 2025-03-24
• Results posted: 2025-03-24

Locations

1 site across 1 country: Denmark