Clinical trial · Interventional
SciBase International Melanoma Pivotal Study
NCT01077050CI-TRIAL-00013245completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this clinical investigation was to determine the safety and effectiveness of the SciBase III device (Test) designed to help distinguish between malignant melanoma and benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological gold standard (Reference). The purpose of the study is to collect data to support a Pre-market Application(PMA) to obtain Food and Drug Administration(FDA) approval to market the SciBase III Electrical Impedance Spectrometer.
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 |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SciBase III Electrical Impedance Spectrometer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- SciBase III
- description
- Subjects with suspected malignant melanoma or lesions designated for total excision were included into the study. To ensure no selection bias, all eligible lesions from a subject were included into the study. All study eligible skin lesion(s) were examined with the investigational device, photographed and removed by an excisional biopsy.
- interventionNames
- Device: SciBase III Electrical Impedance Spectrometer
Primary outcomes (1)
- measure
- SciBase Sensitivity and Specificity
- timeFrame
- Post data lock
- description
- This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device: 1. Sensitivity ≥ 0.90 to detect Melanoma 2. Sensitivity - (1-Specificity) \> 0.00 Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria For inclusion in the study, all subjects had to fulfill all of the following criteria: * Men or women of any ethnic group aged ≥18 years * Primary lesions (i.e., not metastases or recurrent lesions) that the physicians choose to excise. * Lesion ≥ 2 mm in diameter and ≤ 20 mm in diameter * In subjects with multiple skin lesions, all lesions destined for excision must be identified for purposes of study participation. Note: a subject may only be entered into the study once. * The subject is willing and able to read, understand and sign the study specific informed consent form. Exclusion Criteria: Subjects were excluded from the study if they fulfilled any of the following criteria: * Skin surface not measurable, e.g. lesion on a stalk * Skin surface not accessible, e.g. inside ears, under nails * Lesion located on acral skin, e.g. sole or palms. * Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions. * Lesion on hair-covered areas, e.g. scalp, beards, moustaches or whiskers. * Lesion located on genitalia. * Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized. * Lesion located on mucosal surfaces. * Skin is not intact (measurement area) e.g. bleeding or with clinical noticeable ulceration. * Lesion with foreign matter, e.g. tattoo, splinter * Lesion and/or reference located on acute sunburn.
References
Publications (2)
- BACKGROUNDAberg P, Nicander I, Holmgren U, Geladi P, Ollmar S. Assessment of skin lesions and skin cancer using simple electrical impedance indices. Skin Res Technol. 2003 Aug;9(3):257-61. doi: 10.1034/j.1600-0846.2003.00017.x. PMID 12877688
- BACKGROUNDAberg P, Nicander I, Hansson J, Geladi P, Holmgren U, Ollmar S. Skin cancer identification using multifrequency electrical impedance--a potential screening tool. IEEE Trans Biomed Eng. 2004 Dec;51(12):2097-102. doi: 10.1109/TBME.2004.836523. PMID 15605856