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COVID-19
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The purpose of this study is to see if the transvaginal colposcope produces similar results to colposcopy for the screening of cervical cancer. In this study the investigators are using an investigational device called the transvaginal colposcope. The word investigational means that the device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transvaginal digital colposcope (TVCD) | Active Comparator | Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix. |
|
| standard of care screening | Active Comparator | Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transvaginal digital colposcope (TVDC) | Device | TVDC is a miniature colposcope used to obtain images of cervical tissue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree | Up to approximately 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nirmala Ramanujam, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27708 | United States | ||
| AIIMS |
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Cervical images obtained across 6 countries to build a database of 1000+ images to develop AI software for cervical cancer screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transvaginal Digital Colposcope (TVCD) | Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix. transvaginal digital colposcope (TVDC): TVDC is a miniature colposcope used to obtain images of cervical tissue. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transvaginal Digital Colposcope (TVCD) | Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix. transvaginal digital colposcope (TVDC): TVDC is a miniature colposcope used to obtain images of cervical tissue. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree | We have SOC Images from these 514 participants AND the images obtained with our research device. Therefore we have 2 photos for each step in the colposcopy procedure process | Posted | Count of Participants | Participants | Up to approximately 10 minutes |
|
Until pathology results are available, up to approximately 14 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transvaginal Digital Colposcope (TVCD) | Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix. transvaginal digital colposcope (TVDC): TVDC is a miniature colposcope used to obtain images of cervical tissue. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Gallagher | Duke University | 9199701551 | jennifer.gallagher@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2021 | May 16, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 19, 2021 | Jan 27, 2023 | ICF_001.pdf |
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| Standard of care screening | Other | Standard of care screening varies from institution to institution but is either visual inspection with the naked eye, colposcopy, or visual inspection with a camera or microscope |
|
| New Delhi |
| India |
| La Liga Contra el Cancer | Lima | Peru |
| Kilimanjaro Christian Medical Centre | Moshi | Tanzania |
| University Teaching Hospital | Lusaka | Zambia |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| 0 |
| 514 |
| 0 |
| 514 |
| 0 |
| 514 |
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