Post-Approval Study of MelaFind

Melanoma Clinical Trial

Official title:

Post-Approval Study of MelaFind

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01700114
• Other study ID #: Protocol 20111
• Status: Terminated
• Phase: N/A
• First received: October 2, 2012
• Last updated: March 10, 2016
• Start date: November 2012
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: MELA Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect data to describe the real-world use and safety and effectiveness of MelaFind® in a post-approval clinical setting.

Description:

The primary objective of this study to test the hypothesis that, among eligible and evaluable lesions with central histological reference standard status melanoma or high-grade lesion, the relative sensitivity ρ comparing enrolling dermatologists after MelaFind use with enrolling dermatologists if MelaFind were not available is greater than 110%. This represents a clinically meaningful increase in sensitivity.

The secondary objectives of this study are to evaluate real-world use and safety and effectiveness of MelaFind in a clinical setting.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 487
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The lesion is pigmented (i.e., melanin, keratin, blood)

• Clinical management of the lesion by the examining dermatologist is either biopsy of the lesion in toto, or 3-month follow-up of the lesion

• The diameter of the pigmented area is between 2 and 22 millimeters

• The lesion is accessible to the MelaFind hand-held imaging device

• The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form

Exclusion Criteria:

• The patient has a known allergy to isopropyl alcohol

• The lesion has been previously biopsied, excised, or traumatized

• The skin is not intact (e.g., open sores, ulcers, bleeding)

• The lesion is within 1 cm of the eye

• The lesion is on mucosal surfaces (e.g., lips, genitals)

• The lesion is on palmar hands

• The lesion is on plantar feet

• The lesion is on or under nails

• The lesion is located on or in an area of visible scarring

• The lesion contains foreign matter (e.g., tattoo, splinter, marker)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma

Intervention

Device:
• MelaFind
The device is used when a dermatologist chooses to obtain additional information on atypical skin lesions for a decision to biopsy.

Locations

Country	Name	City	State
United States	The Johns Hopkins University	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	AboutSkin Dermatology and DermSurgery	Englewood	Colorado
United States	Dermatology Associates of Tallahassee	Tallahassee	Florida
United States	The Dermatology Group, P.C.	Verona	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
MELA Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available		6 years	No
Secondary	To describe characteristics of patients and lesions with MelaFind, the experience of using MelaFind, distribution of test results, and details on biopsied lesions.		6 years	No