Safety and Performance of a New Coating for Urinary Intermittent Catheters

August 26, 2020 updated by: Coloplast A/S

Clinical Study Investigating Safety and Performance of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers

The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Have given written informed consent and signed letter of authority
  2. Be at least 18 years of age and have full legal capacity
  3. Be a male
  4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits

Exclusion Criteria:

  1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract
  2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
  3. Participating in other interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)
  4. Known hypersensitivity toward any of the test products -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sequence 1
SpeediCath catheter then ZN-D catheter then ZN-C catheter
Device: ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Device: ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Device: SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Experimental: Sequence 2
SpeediCath catheter then ZN-C catheter then ZN-D catheter
Device: ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Device: ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Device: SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Experimental: Sequence 3
ZN-D catheter then SpeediCath catheter then ZN-C catheter
Device: ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Device: ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Device: SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Experimental: Sequence 4
ZN-D catheter then ZN-C catheter then SpeediCath catheter
Device: ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Device: ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Device: SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Experimental: Sequence 5
ZN-C catheter then SpeediCath catheter then ZN-D catheter
Device: ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Device: ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Device: SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
Experimental: Sequence 6
ZN-C catheter then ZN-D catheter then SpeediCath catheter
Device: ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Device: ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
Device: SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Discomfort During Catheterization
Time Frame: 1 day
Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Investigators

  • Principal Investigator: Per Bagi, MD, PhD, Department of Urology, Rigshospitalet Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

February 22, 2013

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • CP235 (Other Identifier: Coloplast)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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