A See and Treat Paradigm for Cervical Pre-cancer

NCT02477124 | Terminated Results

• 1 other identifier: Pro00052865
• Study Type: interventional
• Target: 514
• Locations: 5 countries
• Sites: 5

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).

Conditions

Cervical Pre-cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree

  Up to approximately 10 minutes

Study Arms (2)

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.

Device: transvaginal digital colposcope (TVDC)

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.

Other: Standard of care screening

Interventions

transvaginal digital colposcope (TVDC) DEVICE

TVDC is a miniature colposcope used to obtain images of cervical tissue.

transvaginal digital colposcope (TVCD)

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

standard of care screening

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Children and subjects under 25.

Sponsors & Collaborators

• Duke University: lead

Study Sites (5)

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

AIIMS

New Delhi, India

Location

La Liga Contra el Cancer

Lima, Peru

Location

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

Location

University Teaching Hospital

Lusaka, Zambia

Location

Results Point of Contact

• Title: Jennifer Gallagher
• Organization: Duke University

jennifer.gallagher@duke.edu

9199701551

Study Officials

• Nirmala Ramanujam, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 22, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 18, 2023
• Results First Posted: May 18, 2023

Record last verified: 2023-05

Locations

IN (1); TA (1); ZA (1); US (1); PE (1)