A See and Treat Paradigm for Cervical Pre-cancer

Not Applicable

Terminated

• Conditions: Cervical Pre-cancer
• Interventions: Device: transvaginal digital colposcope (TVDC); Other: Standard of care screening

• Registration Number: NCT02477124
• Lead Sponsor: Duke University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-17
• Study First Posted: 2015-06-22
• Study Start: 2015-09
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Disposition First Submitted: 2022-01-24
• Disposition First Submitted QC: 2022-01-24
• Disposition First Posted: 2022-01-26
• Results First Submitted: 2023-01-31
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-16
• Last Update Submitted: 2023-05-16
• Results First Posted: 2023-05-18
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 514

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transvaginal digital colposcope (TVCD)	transvaginal digital colposcope (TVDC)	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	Standard of care screening	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree	Up to approximately 10 minutes

Trial Locations

Locations (5)

La Liga Contra el Cancer; 🇵🇪 Lima, Peru

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Kilimanjaro Christian Medical Centre; 🇹🇿 Moshi, Tanzania

AIIMS; 🇮🇳 New Delhi, India

University Teaching Hospital; 🇿🇲 Lusaka, Zambia