The Effectiveness of High Resolution Microendoscopy for People Living With HIV

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

163

Participants

Timeline

Start Date

July 30, 2019

Primary Completion Date

March 28, 2024

Study Completion Date

March 28, 2025

Conditions
Anal High Grade Squamous Intraepithelial Lesion
Interventions
DIAGNOSTIC_TEST

mHRME (Mobile High resolution microendoscope)

"Standard of care (SOC) high-resolution anoscopy (HRA) with Lugol's iodine will be performed. The unstained (abnormal) area will be evaluated with mHRME for optical biopsy diagnosis:~1. contrast agent will be applied to anal epithelium (5-10 ml of proflavine hemisulfate (0.01%)),~2. the mHRME will then be inserted and imaging of abnormal tissues will be performed. This will add 2 to 6 minutes per procedure.~This is a single-arm study where all subjects will receive both SOC HRA and experimental mHRME imaging."

DRUG

Proflavine Hemisulfate

Contrast agent will be applied to anal epithelium (5-10 ml of proflavine hemisulfate (0.01%)) to use with the mHRME

DIAGNOSTIC_TEST

High resolution anoscopy

Standard of care (SOC) HRA with Lugol's iodine will be performed.

Trial Locations (3)

10029

Icahn School of Medicine at Mount Sinai, New York

77030

Baylor College of Medicine, Houston

M.D. Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

Icahn School of Medicine at Mount Sinai

OTHER

collaborator

William Marsh Rice University

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

The University of Texas Health Science Center, Houston

OTHER

collaborator

M.D. Anderson Cancer Center

OTHER

collaborator

Medical University of South Carolina

OTHER

lead

Baylor College of Medicine

OTHER

NCT04563754 - The Effectiveness of High Resolution Microendoscopy for People Living With HIV | Biotech Hunter | Biotech Hunter