Feasibility Testing of a Novel Endoscope for Reflectance Confocal Microscopy of Normal Oral Tissue In Vivo

Completed

• Conditions: Oral Tissue
• Interventions: Device: Reflectance Confocal Microscopy (RCM) endoscope device

• Registration Number: NCT03004053
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to obtain images (pictures) of normal oral tissue, which occur inside the mouth, using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy."

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-28
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Healthy volunteers
• Ability to sign informed consent
• Age ≥ 18 years.

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Exclusion Criteria

• Inability to give informed consent.
• Previously known oral disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Volunteers will be identified by the Head and Neck Service	Reflectance Confocal Microscopy (RCM) endoscope device	25 volunteers (Part I - 8 volunteers. Part II - 17 volunteers). during the course of 12 months. The volunteers will be imaged with the endoscope, and the images will be evaluated visually and with qualitative (descriptive) statistics.

Primary Outcome Measures

Name	Time	Method
number of images with acceptable quality	1 year	Each image will be scored either 1 (completely unacceptable), 2 (unacceptable), 3 (possibly acceptable), 4 (acceptable) or 5 (very acceptable) relative to a reference standard The reference standard for appearance of adequate sectioning, resolution and contrast and for detectability of nuclear and cellular features will be the appearance of images and image quality, which we are intimately familiar with, based on the past several years of experience with the existing RCM device for which images of oral mucosa have been well-characterized, well-correlated to histology, and thus are well-understood.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States