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Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia

NCT02420665 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-05-28

No results posted yet for this study

Summary

The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy procedure. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.

Conditions

Interventions

DRUG

Proflavine

0.01% Proflavine applied topically to the cervix after colposcopy and HRME cervical images obtained.

DEVICE

HRME Imaging

HRME images obtained from one visually normal cervical site, and from up to 3 visually abnormal lesions based on exam and/or colposcopic findings.

BEHAVIORAL

Phone Call

Study staff follow up with participant by phone one month after procedure.

PROCEDURE

Colposcopy

Colposcopy performed after visual inspection of cervix.

DRUG

Acetic Acid

3 - 5% added to cervix before visual inspection.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Kathleen Schmeler, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-23
Primary Completion
2021-05-14
Completion
2021-05-14
FDA Drug
Yes
FDA Device
Yes

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 NCT02420665 on ClinicalTrials.gov