CASUS: Improved and Quality Assured Collection of First-void Urine

Plain-language summary

This study evaluated improved, quality-assured collection of first-void urine using the Colli-Pee® device. Women aged 18 and over with a high-risk HPV-positive test result within the previous six months were eligible. It was a non-phase interventional study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Universiteit Antwerpen

Intervention

Colli-Pee® (FV5000 and Small Volumes)

Start date

7/30/2019

Estimated completion

11/27/2019

Countries

Belgium

Related genes

Locations

• Wilrijk, Belgium

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Female
* 18 years and older
* Women with a high-risk HPV positive test result within six months prior to study enrolment.
* Giving informed consent to the research team to contact his/her general practitioner and/or gynaecologist to access details of the participants HPV test results and cervical screening history.
* Able to understand the information brochure/what the study is about.

Exclusion Criteria:

* Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the previous six months prior to study enrolment.
* Participating in another interventional clinical study (where e.g. a medical device, drug, or vaccine is evaluated) at the same time of participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.