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Evaluation the Feasibility of the FOSTI Device

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Optivasive Ltd..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00791609
First Posted: November 14, 2008
Last Update Posted: November 14, 2008
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.
Information provided by:
Optivasive Ltd.
  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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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
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
Study Director: Anatoliy Babchenko Optivasive Ltd.
  More Information

Responsible Party: Anatoliy Babchenko, Optivasive Ltd.
ClinicalTrials.gov Identifier: NCT00791609     History of Changes
Other Study ID Numbers: OpVe-HI-08-001
First Submitted: November 13, 2008
First Posted: November 14, 2008
Last Update Posted: November 14, 2008
Last Verified: November 2008

Keywords provided by Optivasive Ltd.:
cancer