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Diagnostic Imaging Aid for Management of Cervical Lesions

NCT02406365 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 618

Last updated 2015-04-10

No results posted yet for this study

Summary

A handheld digital colposcope which utilizes flurorescent light is being tested for the rapid detection and management of cervical lesions. The handheld research device captures cervical images which with the fluorescent light show the regions of cervical tissue that autofluoresce. The investigators will study the relationship between the level of fluorescence and the samples of tissue (biopsies) obtained from the patient as part of her routine care. The investigators will also compare the efficacy of the hand held device with the data being collected from the other research devices being tested by the team, i.e. the multispectral digital colposcopes.

Conditions

  • Cervical Cancer
  • Cervical Intraepithelial Neoplasias
  • Digital Colposcopy
  • Precancerous Cervical Lesions

Interventions

DEVICE

Diagnostic imaging aid for one-visit management of cervical lesions

Sponsors & Collaborators

  • Brookdale University Hospital Medical Center

    lead OTHER

Principal Investigators

  • Michele Follen, 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
2015-04-30
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02406365 on ClinicalTrials.gov