A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions

RECRUITING

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The purpose of this study is to find out whether using noninvasive methods to study the appearance of lesions can improve diagnostic accuracy before a biopsy is required and help guide treatment planning. The database created to store these images is called an Image Repository, and it will be used to support clinical practice, teaching and training, and future research.The High-resolution OCT (Apollo Medical Optics) device ApolloVue® S100 Image System (medical device Class II) can provide both cross-sectional and en-face images with cellular information.

Conditions:

Skin Lesion Mucosal Lesion

Study Start (Actual) 2021-02-02

Primary Completion (Estimated) 2031-08-02

Study Completion (Estimated) 2031-08-02

Enrollment (Estimated) 5010

Study Type OBSERVATIONAL

Phase N/A

Locations:

📍 New York, New York, United States

Eligibility Criteria

Description

Inclusion Criteria:

* All ages
* Patients with a muco-cutaneous lesion(s) amenable to imaging by non-invasive tools
* Healthy volunteer subjects
* Ability to give informed consent or in the case of pediatric patients, assent and consent from the parent/guardian

Exclusion Criteria:

* Allergy or intolerance to ultrasound gel or mineral oil used for imaging
* Patients who are not able to comply with imaging procedure

Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

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 Registration Dates

First Submitted2021-02-03
First Submitted that Met QC Criteria2021-02-03
First Posted2021-02-08

Study Record Updates

Last Update Submitted that Met QC Criteria2024-01-03
Last Update Posted2024-01-05
Last Verified2024-01