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

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 23, 2015

Primary Completion Date

May 14, 2021

Study Completion Date

May 14, 2021

Conditions
Cervical Cancer
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.

Trial Locations (2)

77026

Lyndon B. Johnson General Hospital, Houston

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

M.D. Anderson Cancer Center

OTHER

NCT02420665 - Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia | Biotech Hunter | Biotech Hunter