N/A
Completed N=227
Does the Aid of MelaFind Affect Clinical Management Decisions
Source: ClinicalTrials.gov NCT01387581 ↗Enrolled (actual)
227
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Sensitivity — 69.5; 78.0; 71.8 percent of true positives
Summary
The objective of this study is to determine and compare the performance of dermatologists (in Germany) on the excision decision against the performance of MelaFind, a non-invasive and objective multi-spectral computer vision system designed as a tool to aid dermatologists in the detection of early melanoma. The hypothesis is that MelaFind's sensitivity is superior to the average excisions sensitivity of dermatologists.
Another objective is to determine and compare the performance of dermatologists (in Germany) with and without the aid of MelaFind. The hypothesis is that the average excision sensitivity of dermatologists with the aid of MelaFind is superior to the average excision sensitivity of dermatologists without the aid of MelaFind.
A similar study was previously conducted with dermatologists in the US (NCT01011153). An exploratory objective is to compare the excision decisions of dermatologists from the previous study (in the US) to dermatologists in in this study (in Germany).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity |
69.5; 78.0; 71.8 | — |
| PRIMARY Specificity |
55.9; 45.8; 54.6 | — |
Eligibility Criteria
Inclusion Criteria
-Only board certified dermatologists
Exclusion Criteria
-May not have previously participated in MELA Protocols 20061, 20081 or 20063
Data sourced from ClinicalTrials.gov (NCT01387581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.