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Evaluation the Feasibility of the FOSTI Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Optivasive Ltd.

Study Description
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Brief Summary:
Feasibility of accurate differentiation between malignant and benign tissue using the FOSTI device on surgically removed tissue

Condition or disease
Cancer

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: 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
Study Start Date : March 2008
Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of subjects who undergo cancer surgery
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791609


Sponsors and Collaborators
Optivasive Ltd.
Investigators
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Study Director: Anatoliy Babchenko Optivasive Ltd.
More Information
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Responsible Party: Anatoliy Babchenko, Optivasive Ltd.
ClinicalTrials.gov Identifier: NCT00791609    
Other Study ID Numbers: OpVe-HI-08-001
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: November 14, 2008
Last Verified: November 2008
Keywords provided by Optivasive Ltd.:
cancer