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NCT01077050 · ClinicalTrials.gov registry record · NA
SciBase International Melanoma Pivotal Study
A NA study of Malignant Melanoma, sponsored by SciBase AB.
- Completed
- Registry status
- NA
- Development phase
- 1,951
- Enrollment target
- 2
- Study locations
NCT01077050: Completed NA study of Malignant Melanoma, sponsored by SciBase AB.
NCT01077050 is a NA study of Malignant Melanoma that has completed, run by SciBase AB. The registered enrollment target is 1,951 participants, above the 114-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (1611% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01077050, a NA study of Malignant Melanoma, has completed, sponsored by SciBase AB.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,951 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE SciBase III Electrical Impedance Spectrometer
Study Locations (2)
Arizona
- University of Arizona - Tucson
Other
- Sahlgrenska University Hospital - Gothenburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,951 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-10 |
| Phase | NA |
What the finished NCT01077050 record still lists
NCT01077050 is an interventional study that assigns participants to a tested intervention. Its 1,951 participants enrollment target places it among the larger protocols in the corpus, above the 114-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (1611% higher).
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.
NCT01077050 reports a single indexed study location in Arizona, Other.
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.
What interventions are being tested in trial NCT01077050?
The interventions under investigation include: SciBase III Electrical Impedance Spectrometer (DEVICE).
Who is sponsoring clinical trial NCT01077050?
This trial is sponsored by SciBase AB, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01077050's enrollment target sits among peer trials
1,951 1st of 28 higher than 28 of 28 other Malignant Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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