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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
  Purpose

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


Condition
Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Optivasive Ltd.:

Enrollment: 50
Study Start Date: March 2008
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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791609

Sponsors and Collaborators
Optivasive Ltd.
Investigators
Study Director: Anatoliy Babchenko Optivasive Ltd.
  More Information

No publications provided

Responsible Party: Anatoliy Babchenko, Optivasive Ltd.
ClinicalTrials.gov Identifier: NCT00791609     History of Changes
Other Study ID Numbers: OpVe-HI-08-001
Study First Received: November 13, 2008
Last Updated: November 13, 2008
Health Authority: Israel: Ethics Commission

Keywords provided by Optivasive Ltd.:
cancer

ClinicalTrials.gov processed this record on May 22, 2013