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COMPLETED NA

SciBase International Melanoma Pivotal Study

NCT01077050 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DEVICE SciBase III Electrical Impedance Spectrometer

Study Locations (2)

Arizona

  • University of Arizona — Tucson

Other

  • Sahlgrenska University Hospital — Gothenburg

Trial Details

FieldValue
Enrollment Target 1,951 participants
Start Date 2010-04
Est. Completion 2011-10
Phase NA

Sponsor

SciBase AB

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01077050

The ClinicalTrials.gov registry entry for NCT01077050 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,951 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SciBase AB, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Malignant Melanoma appearing as the primary indexed condition, and to 1 intervention — of which SciBase III Electrical Impedance Spectrometer is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01077050 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Arizona, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01077050 about?

NCT01077050 is a clinical study titled "SciBase International Melanoma Pivotal Study". 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). ...

What is the current status of trial NCT01077050?

This trial is currently completed. It is a NA study. The enrollment target is 1,951 participants. The study started on 2010-04. Estimated completion is 2011-10.

What conditions does trial NCT01077050 study?

This clinical trial studies the following conditions: Malignant Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01077050?

The interventions under investigation include: SciBase III Electrical Impedance Spectrometer (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01077050?

This trial is sponsored by SciBase AB, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01077050 being conducted?

This trial has 2 study locations across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial