NCT07636668

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
May 2026Jan 2027

Study Start

First participant enrolled

May 13, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

June 9, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 21, 2026

Last Update Submit

June 3, 2026

Conditions

Instructions for UseUsability

Keywords

First-void urineSelf-sampling

Outcome Measures

Primary Outcomes (2)

  • Feedback usability

    Collected data on the usability through questionnaire

    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

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

Secondary Outcomes (1)

  • Volume first-void urine collected

    Baseline (single visit)

Study Arms (1)

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.

Device: First-void urine collection device

Interventions

First-void urine collection deviceDEVICE

Use of a first-void urine collection device

First-void urine collection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Antwerp - Centre for the Evaluation of Vaccination

Edegem, 2650, Belgium

RECRUITING

Central Study Contacts

Alex Vorsters

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 9, 2026

Study Start

May 13, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

June 9, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)