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

Oral Tissue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004053
• Other study ID #: 16-1652
• Status: Completed
• Start date: December 2016
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Oral Tissue

Intervention

Device:
• Reflectance Confocal Microscopy (RCM) endoscope device

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of images with acceptable quality	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

External Links

•   Memorial Sloan Kettering Cancer Center