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Evaluation the Feasibility of the FOSTI Device

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ClinicalTrials.gov Identifier: NCT00791609
Recruitment Status : Unknown
Verified November 2008 by Optivasive Ltd..
Recruitment status was:  Active, not recruiting
First Posted : November 14, 2008
Last Update Posted : November 14, 2008
Sponsor:
Information provided by:

November 13, 2008
November 14, 2008
November 14, 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.
 
Unknown status
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
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00791609
OpVe-HI-08-001
No
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Anatoliy Babchenko, Optivasive Ltd.
Optivasive Ltd.
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Study Director: Anatoliy Babchenko Optivasive Ltd.
Optivasive Ltd.
November 2008