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

NCT ID: NCT04231149

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2018-12-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Test product 2

Test catheter 2

Group Type: EXPERIMENTAL

Test product 3

Intervention Type: DEVICE

Test catheter 3

Comparator

Intervention Type: DEVICE

SpeediCath Flex

Test product 3

Test catheter 3

Group Type: EXPERIMENTAL

Test product 2

Intervention Type: DEVICE

Test catheter 2

Comparator

Intervention Type: DEVICE

SpeediCath Flex

Comparator

SpeediCath Flex

Group Type: ACTIVE_COMPARATOR

Test product 2

Intervention Type: DEVICE

Test catheter 2

Test product 3

Intervention Type: DEVICE

Test catheter 3

Interventions

Test product 2

Test catheter 2

Intervention Type: DEVICE

Test product 3

Test catheter 3

Intervention Type: DEVICE

Comparator

SpeediCath Flex

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Has given written informed consent and signed letter of authority Is at least 18 years of age and has full legal capacity Is a male Willing to comply without using analgetica up to 24 hours prior to catheterisation visits

Exclusion Criteria

Has a previous history of genitourinary disease including congenital abnormalities and surgical procedures performed in the urinary tract Has symptoms of urinary tract infections (frequent urination, stinging and pain at urination) Are participating in any other clinical investigation related to urinary tract system during this investigation (inclusion to termination) Known hypersensitivity toward any of the test products

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Birte Jakobsen, MD

Role: PRINCIPAL_INVESTIGATOR

Coloplast A/S

Locations

Coloplast A/S

Humlebæk, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP290

Identifier Type: -

Identifier Source: org_study_id