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SciBase International Melanoma Pivotal Study | Clinical Trials | Clareo Health

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SciBase International Melanoma Pivotal Study

NCT01077050•SciBase AB

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+2 more criteria

Locations (2)

University of Arizona

Tucson, Arizona, United States

Sahlgrenska University Hospital

Gothenburg, Sweden

Key Dates

Start Date

April 1, 2010

Primary Completion Date

September 1, 2011

Completion Date

October 1, 2011

Last Updated

December 30, 2013

Enrollment

1,951

ACTUAL participants

Conditions

Malignant Melanoma

Interventions

SciBase III Electrical Impedance Spectrometer

DEVICE

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

NCT07371663

Solid CancersNSCLC (Advanced Non-small Cell Lung Cancer)+3 more

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RECRUITINGPHASE1/PHASE2

Modified Vaccine for High Risk or Low Residual Melanoma Patients

NCT01898039

Malignant Melanoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SciBase International Melanoma Pivotal Study

Inclusion Criteria

Exclusion Criteria

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

Modified Vaccine for High Risk or Low Residual Melanoma Patients

AMT-253 in Patients With Advanced Solid Tumours

Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract

Toripalimab Combined With Radiotherapy and Chemotherapy in the Treatment of SNMM After Endoscopic Surgery

Registry of Subjects at Risk of Pancreatic Cancer