Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-01-01 @ 7:59 PM
Study NCT ID:
NCT04610632
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2020-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Pregnancy Test Study on BioBank Samples
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-11', 'studyFirstSubmitDate': '2020-10-27', 'studyFirstSubmitQcDate': '2020-10-29', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement with confirmed pregnancy result', 'timeFrame': '1 week', 'description': 'The percentage agreement between the result obtained when a lay user test a urine sample, and the confirmed pregnancy status of the volunteer providing the sample. Both confirmed positive (pregnant) and negative (not pregnant) samples will be included in the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': "This is a non-clinical lay user study using stored clinical samples from the SPD BioBank.\n\nVolunteers recruited into the study and meeting the criteria will test a randomised pregnant or not pregnant urine sample sourced from SPD's biobank with a new home pregnancy test. Volunteers will be required to follow the product instructions for use (IFU).\n\nThe order of testing will be randomised prior to execution of the protocol, and each urine sample will only be identifiable by a unique reference number. An independent study technician not involved in study conduct will be responsible for blinding the samples.", 'detailedDescription': 'Women will be informed of the opportunity to participate in a study in which they will be required to use a home pregnancy test to test a urine sample provided to them. Interested applicants will be invited to join the study.\n\nVolunteers will be advised that the product they will be testing is under investigation and that the volunteer will not be testing their own urine and therefore volunteers will not learn their own pregnancy status.\n\nVolunteers will be required to consent to the study prior to participation. Each volunteer will test only one device, they will be provided with one investigational device and one urine sample. The order of testing will be randomised prior to execution of the protocol, and each urine sample will only be identifiable by a unique reference number.\n\nWhen ready the volunteer will be required to read the IFU prior to testing the urine sample provided with the investigational device according to the instructions. The volunteer will advise the study technician of the result, who will record this on the result sheet.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'General public', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Aged ≥18 years\n* Willing to give informed consent\n\nExclusion Criteria:\n\n* Currently or previously employed by SPD, Abbott, Alere, Unipath, P\\&G or affiliates\n* Has an immediate relative currently or previously (within last 5 years) employed by SPD, Abbott, Alere, Unipath or P\\&G or affiliates\n* Is a qualified or trainee Healthcare Professional (HCP)\n* Has professional experience of using dipstick type tests or lateral flow devices\n* Has previously taken part in this study\n* Seen the product within the past 6 months'}, 'identificationModule': {'nctId': 'NCT04610632', 'briefTitle': 'Home Pregnancy Test Study on BioBank Samples', 'organization': {'class': 'INDUSTRY', 'fullName': 'SPD Development Company Limited'}, 'officialTitle': 'Home Pregnancy Test Study Lay User Study on BioBank Samples', 'orgStudyIdInfo': {'id': 'PROTOCOL-1147'}}, 'armsInterventionsModule': {'interventions': [{'name': 'home pregnancy test', 'type': 'DIAGNOSTIC_TEST', 'description': 'use of home pregnancy test'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'MK44 3UP', 'city': 'Bedford', 'state': 'Bedfordshire', 'country': 'United Kingdom', 'facility': 'SPD Development Company Ltd.', 'geoPoint': {'lat': 52.13459, 'lon': -0.46632}}], 'overallOfficials': [{'name': 'Sarah Johnson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SPD Development Company Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SPD Development Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}