In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
Prospective observational Study: A single-arm study has one study group consisting of eligible lesions on
eligible patients.
This is a multicenter, prospective, observational, single arm, post-approval study of MelaFind, which will enroll lesions that meet the labeled Indications for Use. Dermatologists? biopsy decisions before and after obtaining MelaFind results will be recorded. Biopsy specimens will undergo central dermatopathology review to determine whether the lesion is melanoma, high-grade, or another type of lesion. Patient follow-up will extend out to 24 months.
Study Population Description
All patients of any age, race, ethnicity, or gender, presenting with pigmented skin lesions that
that meet the Indications for Use stated above and Lesion Inclusion and Exclusion Criteria stated below, including signing the Informed Consent Form, are eligible to participate in this study.
Up to six clinical sites in the US will participate in this study, one in each of the first six states in which MelaFind is commercially available. Three of the sites will be located in urban settings, and three will be located in a suburban or rural setting. At least 50% of the sites will new, i.e., they did not participate in the MelaFind pivotal study. Some sites will be academic centers and some private practices.
Sample Size
It is anticipated that at least 78 patients with one or more eligible and evaluable
histologically-confirmed melanoma and/or high-grade lesion will be enrolled in 12 months.
Data Collection
The primary objective is to estimate the relative sensitivity ñ and test the null hypothesis
that the ñ comparing enrolling dermatologists after MelaFind use with enrolling dermatologists if MelaFind were not available is greater than 110%.
Secondary Objectives
Real-World Use of MelaFind
1. To describe characteristics of patients with lesions imaged with MelaFind, including age, gender, race, ethnicity, and Fitzpatrick skin type
2. To describe characteristics of lesions imaged with MelaFind, particularly the proportion of such lesions that meet the labeled Indications for Use
3. To describe the experience of using MelaFind to image lesions, particularly:
a. Number of imaging attempts
b. Proportion of lesions for which an image that passes automatic image QC algorithms is not obtained (non-evaluables)
4. To describe the distribution of MelaFind test results (positive, negative) among lesions with images that pass automatic image QC algorithms
Safety and Effectiveness of MelaFind
5. To describe the proportion of lesions that are biopsied among lesions with positive MelaFind test results, among lesions with negative MelaFind test results, and among non-evaluables (lesions with images that do not pass automated QC algorithms)
6. Among biopsied lesions:
a.To describe biopsy results based on central histological reference standard (melanoma, high-grade lesion [high-grade dysplastic nevus, atypical melanocytic hyperplasia/proliferation], other) among lesions with positive MelaFind test results, among lesions with negative MelaFind test results, and among non-evaluables
b. o estimate sensitivity of MelaFind to melanomas and high-grade lesions, based on central histological reference standard
c. To estimate specificity of MelaFind for non-melanomas and non-high-grade lesions, based on central histological reference standard
7. To describe lesion management decisions of dermatologists before and after MelaFind evaluations:
a. For all lesions: among non-evaluable lesions, among evaluable lesions with positive MelaFind test results, and among evaluable lesions with negative MelaFind test results
b. For eligible and evaluable lesions that are neither melanomas nor high-grade lesions: ratio of false-positive fraction (FPF) after MelaFind evaluation to FPF if MelaFind were not available.
c. For biopsied lesions: true positives, true negatives, false positives, false negatives, and biopsy ratios (number of false positives for each true positive)
d. For biopsied lesions: ratio of false-positive fraction after MelaFind evaluation to false-positive fraction if MelaFind were not available (relative false-positive fraction)
e. For biopsied lesions: ratio of biopsy ratio after MelaFind evaluation to biopsy ratio if MelaFind were not available (relative biopsy ratio)
8. Among lesions without biopsy after 2-year follow-up, describe the results of all available MelaFind evaluations
Followup Visits and Length of Followup
Patient follow-up will extend out to 24 months.
Patients with lesions evaluated with MelaFind during
the enrollment period, but not biopsied at that time, will be scheduled for follow-up appointments at 1 year ±3 months and 2 years ±3 months.
