Clinical trial · Observational
Post-Approval Study of MelaFind
NCT01700114CI-TRIAL-00021323terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): FDA withdrew requirement to complete study
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MelaFind | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Relative sensitivity comparing enrolling dermatologists after MelaFind use with enrolling dermatoligsts if MelaFind were not available
- timeFrame
- 6 years
Secondary outcomes (1)
- measure
- To describe characteristics of patients and lesions with MelaFind, the experience of using MelaFind, distribution of test results, and details on biopsied lesions.
- timeFrame
- 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.