Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT06120205
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-18
First Post:
2023-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-18', 'mcpReleaseN': 6, 'releaseDate': '2025-09-02'}], 'estimatedResultsFirstSubmitDate': '2025-09-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 870}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2023-10-27', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: Detection of hrHPV in self-collect and clinician collect samples', 'timeFrame': 'Samples tested within 7 days of collection', 'description': 'PPA/NPA (Positive Percent Agreement)/(Negative Percent Agreement) of hrHPV detection of self-collected and clinician collected samples'}, {'measure': 'Safety: SAE rate', 'timeFrame': '6-14 days following collections', 'description': 'SAE rate is equivalent for both self-collect and clinician collect interventions'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['screening', 'self-collect', 'HPV', 'cervical cancer screening'], 'conditions': ['Hpv', 'HPV 16 Infection', 'HPV Infection', 'High Risk HPV']}, 'referencesModule': {'references': [{'pmid': '12090030', 'type': 'BACKGROUND', 'citation': 'Onabolu AO, Oluwole OS, Bokanga M. Loss of residual cyanogens in a cassava food during short-term storage. Int J Food Sci Nutr. 2002 Jul;53(4):343-9. doi: 10.1080/09637480220138151.'}, {'pmid': '40388167', 'type': 'DERIVED', 'citation': 'Fitzpatrick MB, Behrens CM, Hibler K, Parsons C, Kaplan C, Orso R, Parker L, Memmel L, Collins A, McNicholas C, Crane L, Hwang Y, Sutton E, Coleman J, Kuroki L, Harshberger K, Williams S, Jennings A, Buccini F, Gillis L, Novetsky AP, Hawkes D, Saville M, Depel T, Aviki E, Sheth SS, Conageski C. Clinical Validation of a Vaginal Cervical Cancer Screening Self-Collection Method for At-Home Use: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2511081. doi: 10.1001/jamanetworkopen.2025.11081.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this method comparison study is to compare the detection of hrHPV collected using the Teal Wand Self-Collection device to hrHPV detected from HCP (health care provider) cervical collection using primary HPV testing assays.\n\nParticipants will be asked to use the Teal Wand to provide a self-collected sample prior to a healthcare provider collected sample to be tested for hrHPV. Secondary measure will include usability and preferences.', 'detailedDescription': 'To demonstrate that participants who are representative of the intended use population can understand the Instructions for Use (IFU) and appropriately use the Teal self-collection device to collect adequate vaginal cells/material for use in primary hrHPV screening (primary outcome).\n\nTo produce sufficient primary hrHPV test results following self-collection, as compared to the current SoC method of HCP specimen collection, when paired samples are tested using FDA approved primary hrHPV assays (Roche cobas and/or BD OnClarity).\n\nPrimary Effectiveness Objective\n\n• To evaluate the performance of a self-collect device for hrHPV detection as compared to standard of care (SoC) by:\n\n* Agreement of hrHPV self-collected sample(s) as compared to HCP-collected sample results.\n* Calculating the invalid rate of tested samples.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Group 1: Inclusion Criteria - General Population Group\n\n1. Participant is 25 to 65 years of age and willing to provide informed consent.\n2. Participant has an intact cervix.\n\nGroup 2: Inclusion Criteria - Enriched Population Group\n\n1. Participant is 25 to 65 years of age and willing to provide informed consent.\n2. Participant has an intact cervix.\n3. One or more of the below:\n\n * Prior diagnosis of hrHPV within previous 6 months and/or\n * Positive cervical Pap cytology result (ASCUS, ASC-H, LSIL, HSIL, SCC, AIS) within previous 6 months and/or\n * Presenting for colposcopy/LEEP/excisional intervention\n\nExclusion Criteria - All Groups\n\n1. Participant has impaired decision-making capacity or is unable to provide informed consent.\n2. Participant has undergone partial or complete hysterectomy including removal of the cervix.\n3. Participant on whom any form of cervical tissue alteration or surgery has been performed within the prior \\< 5 months, including: conization, loop electrosurgical excision procedure (LEEP), laser ablative surgery, or cryotherapy.\n4. Participant is pregnant (based on self-reporting).\n5. Participant who reports or is experiencing menstrual bleeding.\n6. Participant is participating in another clinical study for an investigational device, drug, or biologic that, in the investigator's opinion, would interfere with the results of this study.\n7. Any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection."}, 'identificationModule': {'nctId': 'NCT06120205', 'briefTitle': 'SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teal Health, Inc.'}, 'officialTitle': 'SELF-CERV Pivotal Study: Method Comparison of Self-collection Using the Teal Wand Self-Collection Device and HCP (Health Care Provider) Cervical Collection for Detection of High-risk HPV (hrHPV) for Cervical Cancer Screening', 'orgStudyIdInfo': {'id': 'CLN-TP-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Self-Collection / Clinician Collection', 'description': 'Patient serves as own comparator/control in this method comparison study where the investigational intervention is use of the self-collect device and the comparator is the standard of care clinician collection.', 'interventionNames': ['Device: Teal Wand Self-Collection Device Group']}], 'interventions': [{'name': 'Teal Wand Self-Collection Device Group', 'type': 'DEVICE', 'otherNames': ['Clinician Collection'], 'description': 'Participants will use the Instructions for Use to perform self-collection of vaginal cells and material using the Teal Wand Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A healthcare provider collected sample will be performed by a clinician after self-collection. The patient will serve as their own comparator/control.', 'armGroupLabels': ['Self-Collection / Clinician Collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham OBGYN / Alabama Clinical Therapeutics', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Planned Parenthood Northern California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Planned Parenthood Southern New England', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '70817', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': "Woman's Hospital", 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Planned Parenthood League of Massachusetts', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '62208', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Planned Parenthood St. Louis Region', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Langone Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': "Unified Women's Clinical Research Raleigh", 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': "Unified Women's Clinical Research - Lyndhurst", 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '77023', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Planned Parenthood Gulf Coast', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified results only'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teal Health, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}