Instructions for UseSCIONCT07636668
Sample Collection and Instruction Optimization
A study testing First-void urine collection device in people with Instructions for Use and Usability, run by Universiteit Antwerpen at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Instructions for Use, Usability
- What is being tested?
- First-void urine collection device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 13 May 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Naïve to first-void urine collection (standard urine cup is allowed)
- Able to understand the information brochure and what the study is about
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University of Antwerp - Centre for the Evaluation of Vaccination
Edegem, 2650
Pierre Van Damme, +32 3 265 2130, pierre.vandamme@uantwerpen.be
About this study
Official title: SCIO: 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.
Read the 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.
- Conditions
- Instructions for Use, Usability
- Being tested
- First-void urine collection device
- Keywords
- First-void urine, Self-sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First-void urine collection deviceDevice
Use of a first-void urine collection device
| Study group | Role | What they receive |
|---|---|---|
| First-void urine collection | Experimental | Use of first-void urine device and filling out questionnaire on the instructions for use and the usability after collection. Receives: Device: First-void urine collection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feedback usability
Collected data on the usability through questionnaire
Measured: Immediately after use of the first-void urine collection device by participants
Feedback instructions for use
Data collected on the instructions for use through questionnaire
Measured: Immediately after use of the first-void urine collection device by participants
Secondary outcomes (1)
Volume first-void urine collected
Volume (in mL) of first-void urine sample collected by using the device
Measured: Baseline (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start13 May 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Instructions for UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Van Damme, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636668
- Sponsor's protocol ID
- B3002026000061
- Acronym
- SCIO
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCIO: Sample Collection and Instruction Optimization
- ClinicalTrials.gov ID
- NCT07636668
- Acronym / sponsor ID
- SCIO / B3002026000061
- Conditions
- Instructions for Use, Usability
- Keywords
- First-void urine, Self-sampling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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)
| Arm | Type | Receives |
|---|---|---|
| First-void urine collection | Experimental | Device: First-void urine collection deviceUse of first-void urine device and filling out questionnaire on the instructions for use and the usability after collection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Naïve to first-void urine collection (standard urine cup is allowed)
- Able to understand the information brochure and what the study is about
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First-void urine collection deviceUse of a first-void urine collection device | Device | First-void urine collection |
Primary outcome
Feedback usability
Time frame: Immediately after use of the first-void urine collection device by participants
Collected data on the usability through questionnaire
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
1 secondary outcome
Volume first-void urine collected
Time frame: Baseline (single visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First-void urine collection device in people with Instructions for Use and Usability, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Vorsters (+32 3 265 91 30, alex.vorsters@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feedback usability (time frame: Immediately after use of the first-void urine collection device by participants). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.