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Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia

NCT02406352 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 618

Last updated 2015-04-10

No results posted yet for this study

Summary

Although cervical cancer is a preventable cancer, every year more than one-quarter of a million women die worldwide from this disease. Internationally and nationally, cervical cancer is a disease that affects predominantly women who are poor and who live in resource poor settings. With the device the investigators are developing, known as the Multispectral Digital Colposcope with probe, our goal is to make detection of precancerous cervical lesions easier for the patient and for her provider. For the patient, our goal is to reduce the number of clinical visits needed to obtain a diagnosis and treatment and consequently to reduce the resulting fear and anxiety which usually accompanies an abnormal Pap smear. For the provider and the health care system, our goal is to obtain a more accurate diagnosis than the currently available diagnostic methods.

Conditions

  • Carcinoma in Situ of Uterine Cervix
  • Cervical Intraepithelial Neoplasias
  • High Grade Cervical Intraepithelial Neoplasia

Interventions

DEVICE

Multispectral Digital Colposcope with probe

Cervical images will be obtained with the Multispectral Digital Colposcope. Spectroscopic data will be obtained with the probe from eligible patients who provided consent to participate in the study. The standard of care for research participants will not change.

Sponsors & Collaborators

  • Brookdale University Hospital Medical Center

    lead OTHER

Principal Investigators

  • Michele Follen, MD, PhD · Brookdale University Hospital and Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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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 NCT02406352 on ClinicalTrials.gov