Evaluation the Feasibility of the FOSTI Device

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Optivasive Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Optivasive Ltd.
ClinicalTrials.gov Identifier:
NCT00791609
First received: November 13, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

November 13, 2008
November 13, 2008
March 2008
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No Changes Posted
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Evaluation the Feasibility of the FOSTI Device
Evaluation the Feasibility of the FOSTI Device Accurately and in a Real Time Way to Differentiate Malignant From Benign Tissue (Performed ex Vivo) in Cancer Surgery

Feasibility of accurate differentiation between malignant and benign tissue using the FOSTI device on surgically removed tissue

Characterization of the optical fiber sensor's interaction with the tissue.

Creating a database of tissue lesions and their 'optical signature' (lesion classifier).

Optimization of the FOSTI device by minimizing the false-positive and false-negative results.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

The study population will consist of subjects who undergo cancer surgery

Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
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Inclusion Criteria:

  • Subjects of all ages.
  • Subject is able, agree and sign the Informed Consent Form.

Exclusion Criteria:

  • Subject has any conditions, which precludes compliance with study
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00791609
OpVe-HI-08-001
No
Anatoliy Babchenko, Optivasive Ltd.
Optivasive Ltd.
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Study Director: Anatoliy Babchenko Optivasive Ltd.
Optivasive Ltd.
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP