Sample Collection and Instruction Optimization

SCIO: Sample Collection and Instruction Optimization

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07636668

Acronym

SCIO

Enrollment

Registered

2026-06-09

Start date

2026-05-13

Completion date

2027-01-01

Last updated

2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Instructions for Use, Usability

Keywords

First-void urine, Self-sampling

Brief summary

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.

Detailed description

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.

Interventions

DEVICEFirst-void urine collection device

Use of a first-void urine collection device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

Primary purpose: Usability study (device feasibility with 30 participants and, if necessary, another cohort of 30 participants if substantial adaptations are needed to be made between cohorts)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Feedback usability	Immediately after use of the first-void urine collection device by participants	Collected data on the usability through questionnaire
Feedback instructions for use	Immediately after use of the first-void urine collection device by participants	Data collected on the instructions for use through questionnaire

Secondary

Measure	Time frame	Description
Volume first-void urine collected	Baseline (single visit)	Volume (in mL) of first-void urine sample collected by using the device

Countries

Belgium

Contacts

CONTACTAlex Vorsters

alex.vorsters@uantwerpen.be+32 3 265 91 30

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026