Precision Optical Guidance for Oral Biopsy

Conditions

• Oral Lesions

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• High Resolution Microendoscope (HRME) — DEVICE
  The High Resolution Microendoscope (HRME) take pictures of a very small area of the lining of the mouth, about the size of a pencil tip, but at high magnification.
• Optical Mapping Scope — DEVICE
  The optical mapping scope displays a wide area of the lining of the mouth (about the size of the top of a soda can) by shining different colors of light into the mouth and taking pictures.
• Proflavine hemisulfate — DRUG
  A coloring substance (a fluorescent dye which glows green in the dark), called proflavine hemisulfate, will be painted on areas of the mouth with a cotton tip applicator to help improve the pictures

Study Details

To learn if a new type of imaging device called the Active Biopsy Guidance System can help doctors to decide when and where to perform invasive biopsies of mouth lesions.

Key Dates

Start date

Jun 15, 2023

Status verified

Apr 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

90 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: The Active Biopsy Guidance System
  This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):

Primary Outcome Measure

To establish a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology [ Time Frame: Through study completion an average of 1 year. ]

Central Contacts

• Ann Gillenwater, MD
  (713) 792-8841
  [email protected]

Locations (1)

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