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NCT Number: NCT07636668

Sample Collection and Instruction Optimization

The aim of this study is to improve the instructions for use and to evaluate the usability of a novel first-void urine collection device.

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Key information

Conditions

Instructions for Use Usability

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Antwerp - Centre for the Evaluation of Vaccination

Edegem, 2650, Belgium

Location status: Recruiting

Location contact

Pierre Van Damme

CONTACT

[email protected]

+32 3 265 2130

About this study

Participants are asked to try a novel first-void urine collection device and give feedback on the instructions and usability of the device through a questionnaire. Further, only the volume of the collected sample is measured. A first group of 30 participants (15 men and 15 women) will be asked for a one-time visit. If any substantial changes need to be made based on the results of the questionnaire, a second group of 30 participants will be asked to evaluate the adapted version.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Naïve to first-void urine collection (standard urine cup is allowed)
  • Able to understand the information brochure and what the study is about

Treatment and study plan

First-void urine collection device

Device

Use of a first-void urine collection device

Primary outcomes

  1. Feedback usability

    Time frame: Immediately after use of the first-void urine collection device by participants

    Collected data on the usability through questionnaire

  2. Feedback instructions for use

    Time frame: Immediately after use of the first-void urine collection device by participants

    Data collected on the instructions for use through questionnaire

Secondary outcomes

  1. Volume first-void urine collected

    Time frame: Baseline (single visit)

    Volume (in mL) of first-void urine sample collected by using the device

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Vorsters

CONTACT

[email protected]

+32 3 265 91 30

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Registry information

Official study title

SCIO: Sample Collection and Instruction Optimization

Acronym: SCIO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

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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