Post-Approval Study of MelaFind

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

487 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Pigmented Skin Lesions With MelaFind(R) System

NCT00434057

Melanoma

COMPLETED PHASE3

Survey Study - Sensitivity Comparison Between MelaFind and Physician Group

NCT01011153

Melanoma

COMPLETED

Does the Aid of MelaFind Affect Clinical Management Decisions

NCT01387581

Melanoma

COMPLETED

Interferon Alfa-2b in Treating Patients With Melanoma and Early Lymph Node Metastasis

NCT00004196

Melanoma (Skin)

COMPLETED PHASE3

Comparing Follow-Up Schedules in Patients With Newly Diagnosed Stage IB or Stage II Melanoma

NCT01018004

Melanoma (Skin)

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MelaFind

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes