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| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P090012 / PAS001 |
| Date Original Protocol Accepted |
11/01/2011
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| Date Current Protocol Accepted |
10/22/2014
|
| Study Name |
PAS of MelaFind
|
| Device Name |
MELAFIND
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
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.
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| Study Population |
All patients of any age, race, ethnicity, or gender, presenting with pigmented skin lesions that meet the Indications for Use and lesion Inclusion and Exclusion Criteria, 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. 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 be new, i.e., they did not participate in the MelaFind pivotal study. Some sites will be academic centers and some private practices.
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| 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.A total of 720 patients and a total number of lesions to range from 720 up to about 3600 are expected to be enrolled in the study.
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| Key Study Endpoints |
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 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. To 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
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| Follow-up Visits and Length of Follow-up |
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. If a patient returns to the clinic for a lesion examination anytime between enrollment and the 2 year follow-up visit, per the dermatologists standard of care, follow-up visit data will be collected and
analyzed as described in the statistical analysis section.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
The PAS was terminated because the original device was modified in both software and firmware. The safety and effectiveness of the modified device were supported by a reader study, and the changes were approved in PMA supplements (P090012/S010, and P090012/S011) in 2016
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| Actual Number of Sites Enrolled |
The PAS was terminated because the original device was modified in both software and firmware. The safety and effectiveness of the modified device were supported by a reader study, and the changes were approved in PMA supplements (P090012/S010, and P090012/S011) in 2016
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| Patient Follow-up Rate |
The PAS was terminated because the original device was modified in both software and firmware. The safety and effectiveness of the modified device were supported by a reader study, and the changes were approved in PMA supplements (P090012/S010, and P090012/S011) in 2016
|
| Final Safety Findings |
The PAS was terminated because the original device was modified in both software and firmware. The safety and effectiveness of the modified device were supported by a reader study, and the changes were approved in PMA supplements (P090012/S010, and P090012/S011) in 2016
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| Final Effect Findings |
The PAS was terminated because the original device was modified in both software and firmware. The safety and effectiveness of the modified device were supported by a reader study, and the changes were approved in PMA supplements (P090012/S010, and P090012/S011) in 2016
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| Study Strengths & Weaknesses |
The PAS was terminated because the original device was modified in both software and firmware. The safety and effectiveness of the modified device were supported by a reader study, and the changes were approved in PMA supplements (P090012/S010, and P090012/S011) in 2016
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| Recommendations for Labeling Changes |
Labeling update is not needed. The updated User Guide (dated 8/17/2016) already presents relevant instructions on the most recent device model available in the commercial setting.
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