Clinical trial · Interventional
Elucid Labs AIDA™ - Labelled Image Acquisition Protocol
Acquiring Images of Pigmented Skin Lesions With the Artificial Intelligence Dermatology Assistant (AIDA™) and Concurrent in Vivo Assessment for the Evaluation of Diagnostic Accuracy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Diagnosis of melanoma involves physical examination of the lesion with many dermatologists adjunctively employing dermoscopes. The rate of misdiagnosis of melanoma remains significant, along with a high rate of referral to biopsy. Elucid Labs (Waterloo, Ontario) has developed a novel handheld, digital dermoscope with accompanying visualization and analysis software - the Artificial Intelligence Dermatology Assistant (AIDA™). Apart from collecting conventional demoscopic images, AIDA also collects images at various spectral bands. The aim of this study is to understand and quantify the value of this novel adjunctive information for dermatologists diagnosing atypical skin lesions.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma of the Skin | Skin Basal Cell Carcinoma | ALIAS | 0.90 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Squamous Cell Carcinoma of the Skin | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artificial Intelligence Dermatology Assistant (AIDA™) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Acquisition of Lesion Images with AIDA
- description
- Subjects presenting with atypical skin lesions referred for biopsy will have their lesion imaged using the Artificial Intelligence Dermatology Assistant (AIDA™) study device
- interventionNames
- Device: Artificial Intelligence Dermatology Assistant (AIDA™)
Primary outcomes (2)
- measure
- Sensitivity of in-clinic dermatologist diagnosis using AIDA™ compared to standard dermoscopy and physical examination alone
- timeFrame
- Average of 4 weeks
- description
- The investigator will review the standard dermoscopy image for the lesion, score it according to the ABCD rule, and state their diagnosis (malignant, dysplastic, or benign) and their diagnostic confidence using a visual analog scale. Subsequently, the investigator will review the AIDA™ outputs and again state their diagnosis and confidence. The sensitivity of those in-clinic diagnoses will be determined by using the definitive diagnoses established in the histopathology reports. The sensitivity of a diagnostic technique determines the probability of a positive test result in a person who has the disease. This is defined according to the equation: TP/(TP + FN) . In this equation, TP is the number of true-positive and FN is the number of false-negative results.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Is 18 years of age or older 2. Has provided informed consent to participate in the study 3. Is being evaluated by a dermatologist for at least one pigmented skin lesionscheduled for biopsy and meeting the following: 1. Has a diameter of at least 1 mm and at most 10 mm 2. Is accessible to the study device (allows for complete seal of device with skin-ie. no ambient light leakage) 3. Is not within 1 cm of the eyes, on mucosal surfaces, palmar hands, plantarfeet, or under nails 4. Is intact (eg. no open sores, ulcers, bleeding) 5. Has not previously been biopsied, excised or traumatized 6. Does not contain visible scarring or foreign material (eg. tattoos, etc.) Exclusion Criteria: 1\. Any allergy to isopropyl alcohol
References
Publications (0)
Data not yet available