A See and Treat Paradigm for Cervical Pre-cancer

Duke University

Status: Terminated

Conditions: Cervical Pre-cancer

Treatments: Other: Standard of care screening; Device: transvaginal digital colposcope (TVDC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02477124

Pro00052865

Details and patient eligibility

About

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).

Enrollment: 514 patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the treatment of cervical cancer.
• Age 25 and greater
• Patients of all ethnic backgrounds will be included.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

• Children and subjects under 25.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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514 participants in 2 patient groups

transvaginal digital colposcope (TVCD)

Active Comparator group

Description:

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.

Treatment:

Device: transvaginal digital colposcope (TVDC)

standard of care screening

Active Comparator group

Description:

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.

Treatment:

Other: Standard of care screening