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OpenTrials
Completed

NCT Number: NCT01800903

Safety and Performance of a New Coating for Urinary Intermittent Catheters

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

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Key information

Conditions

Intermittent Urethral Catheterization

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ZN-D catheter

Device

ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.

ZN-C catheter

Device

ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.

SpeediCath catheter

Device

The Speedicath cathere is CE-marked and commercially available.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 28, 2013
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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