A See and Treat Paradigm for Cervical Pre-cancer

Cervical Pre-cancer Clinical Trial

Official title:

A See and Treat Paradigm for Cervical Pre-cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02477124
• Other study ID #: Pro00052865
• Status: Terminated
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 2020

Study information

• Verified date: May 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 514
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Pre-cancer
• Uterine Cervical Dysplasia

Intervention

Device:
• transvaginal digital colposcope (TVDC)
TVDC is a miniature colposcope used to obtain images of cervical tissue.

Other:
• Standard of care screening
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

Locations

Country	Name	City	State
India	AIIMS	New Delhi
Peru	La Liga Contra el Cancer	Lima
Tanzania	Kilimanjaro Christian Medical Centre	Moshi
United States	Duke University Medical Center	Durham	North Carolina
Zambia	University Teaching Hospital	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Countries where clinical trial is conducted

United States,  Zambia,  India,  Peru,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree		Up to approximately 10 minutes