Non-invasive Melanoma Assessment Using a Topical Fluoresc... | NCT02193581

Studies
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging

NCT02193581

Sponsor

Orlucent, Inc

Status

Completed

Last Update Posted

Feb 19, 2018Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Skin Lesion

Interventions

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2017Actual

Primary Completion Date

Dec 1, 2017Actual

Completion Date

Dec 1, 2017Actual

First Submitted Date

Jul 8, 2014

First Submission Date that Met QC Criteria

Jul 15, 2014

First Posted Date

Jul 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2018

Last Update Posted Date

Feb 19, 2018Actual

Name	Class
Hadassah Medical Organization	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The use of MDS to access the presence of melanoma in the skin.

Detailed Description

A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suspicious skin lesions.		Patients with a suspicious skin lesion referred for a biopsy are tested using MDS	Device: MDS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MDS	Device	Patients with a suspicious lesion, referred for a biopsy is tested using MDS.	Suspicious skin lesions.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The MDS produces a score between 1 to 10.	The score is a composite of the images of the mole, plus demographic and clinical information. The score is ranked from 1 to 10, with 1 being the lowest risk for melanoma, and 10 being the highest risk.	28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy.
The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
Male and female ≥ 21 years old.
Subject is capable of giving written informed consent.
Primary excision.

Exclusion Criteria:

The lesion is less than 1 cm from the eyes.
The lesion is on the palms of hands or soles of the feet.
Mucosal lesion.
Pregnant females.
Low study procedure compliance.
Patients who are mentally or physically unable to comply with all aspects of the study.
Undergoing chemotherapy.
Minor or legally incompetent and not able to sign the consent form.
Patient previously tested by MDS and was diagnosed with melanoma during the study.
Sensitivity to fluorescein

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Individual referred by a dermatologist or plastic surgeon for a skin biopsy or lesion excision.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sharon Merims, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem			Israel