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Project-0027. Lay User Usage Study

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ClinicalTrials.gov Identifier: NCT02636166
Recruitment Status : Completed
First Posted : December 21, 2015
Last Update Posted : December 21, 2015
Sponsor:
Collaborator:
Illingworth Research Ltd
Information provided by (Responsible Party):
SPD Development Company Limited

Brief Summary:

Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial centre and provide a sample of urine from the same void for further testing.

Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.

Follow-up information will be required from all volunteers as both additional urine sample(s) and pregnancy information to establish true pregnancy status at the study visit.


Condition or disease Intervention/treatment Phase
Pregnancy Other: Clearblue Investigational Pregnancy test Other: Professional pregnancy test Other: Clearblue Marketed Pregnancy test Not Applicable

Detailed Description:

Eligible volunteers will be recruited into the study and provide informed consent. Volunteers will then test their urine sample with the investigational HPT according to the device Instructions for use and record their result onto the results sheet. A sample of urine from the same void will be obtained for further testing by the study technicians.

The technician will then test the volunteer's sample with a second investigational HPT, a professional use pregnancy test and a Clearblue Digital HPT, the results of which will be used to provide the volunteer with her pregnancy test result. During technician testing, the volunteer will complete the device usability and leaflet comprehension questionnaires.

At the end of the study visit, all volunteers will be provided with materials to allow follow-up for the determination of pregnancy status.

The majority of volunteers will be requested to provide one additional urine sample, collected 2 days after the study visit. If early pregnancy is suspected the volunteer will be requested to provide an additional 7 daily urine samples following the study visit. All volunteers will be required to provide details of pregnancy status (documented menses or pregnancy confirmation by health care professional) after the study visit.

True pregnancy status will be determined by laboratory tests and clinical information. The study will continue until a minimum of 300 pregnant and 300 not pregnant volunteers have completed the study.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 943 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Project-0027 Lay User Usage Study
Study Start Date : July 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Pregnancy test

Clearblue investigational Pregnancy test

Clearblue Marketed pregnancy test

Professional pregnancy test

Other: Clearblue Investigational Pregnancy test
Clearblue Investigational Pregnancy test

Other: Professional pregnancy test
Alere Professional use pregnancy test

Other: Clearblue Marketed Pregnancy test
Clearblue Marketed Pregnancy test




Primary Outcome Measures :
  1. Number of participants recording the correct pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status [ Time Frame: 3 months ]
    The accuracy of the investigational HPT in volunteer hands compared to pregnancy status


Secondary Outcome Measures :
  1. Number of participants recording the same pregnancy test result as a laboratory technician when testing their own urine sample with the investigational HPT. [ Time Frame: 3 months ]
    The agreement between volunteer and technician results using the investigational HPT

  2. Number of participants recording a false positive or false negative pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status. [ Time Frame: 3 months ]
    The estimated sensitivity and specificity of the investigational HPT

  3. Calculation of the level of certainty a user can have if the device gives a pregnant (positive predictive value (PPV)) or not pregnant result (Negative predictive value(NPV)). [ Time Frame: 3 months ]
    The estimated NPV and PPV of the investigational HPT

  4. Number of participants correctly answering questions about the product when referencing the instructions for use (IFU) leaflet. [ Time Frame: 3 months ]
    Volunteer leaflet comprehension of the IFU

  5. Participants opinion on using the product. [ Time Frame: 3 months ]
    Volunteer usability of the IFU



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Aged 18 or over
  • Willing to conduct a personal pregnancy test and reveal their pregnancy status
  • Willing to give informed consent

Exclusion Criteria:

  • Currently or previously employed by SPD Development Company Ltd. (SPD), Alere, Unipath, Procter and Gamble (P&G), or affiliates.
  • Has an immediate relative* currently or previously employed by SPD, Alere, Unipath or P&G or affiliates
  • Previously used the investigational HPT within the last six months
  • Healthcare professionals (HCP's) with professional experience either using lateral flow based devices or conducting near patient testing
  • Confirmed to be pregnant by a healthcare professional and beyond the first trimester
  • Taken a hormonal preparation containing human chorionic gonadotropin (hCG) in the last month, e.g. Pregnyl®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636166


Locations
United Kingdom
Illingworth Research Ltd
Macclesfield, Chester, United Kingdom, SK11 7QJ
Sponsors and Collaborators
SPD Development Company Limited
Illingworth Research Ltd
Investigators
Principal Investigator: Juliet Hulse Illingworth Research Ltd

Responsible Party: SPD Development Company Limited
ClinicalTrials.gov Identifier: NCT02636166     History of Changes
Other Study ID Numbers: PROTOCOL-0772
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: December 21, 2015
Last Verified: October 2015

Keywords provided by SPD Development Company Limited:
Pregnancy