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

March 1, 2022 updated by: Memorial Sloan Kettering Cancer Center
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."

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Head and Neck clinic

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Volunteers will be identified by the Head and Neck Service
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.
Device: Reflectance Confocal Microscopy (RCM) endoscope device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of images with acceptable quality
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

December 21, 2016

First Submitted That Met QC Criteria

December 22, 2016

First Posted (Estimate)

December 28, 2016

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-1652

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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