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A See and Treat Paradigm for Cervical Pre-cancer

NCT02477124 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2023-05-18

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Nirmala Ramanujam, PhD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • United States
  • India
  • Peru
  • Tanzania
  • Zambia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02477124 on ClinicalTrials.gov