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Evaluation the Feasibility of the FOSTI Device

NCT ID: NCT00791609

Last Updated: 2008-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cancer

Keywords

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cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Optivasive Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Optivasive Ltd.

Principal Investigators

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Anatoliy Babchenko

Role: STUDY_DIRECTOR

Optivasive Ltd.

Other Identifiers

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OpVe-HI-08-001

Identifier Type: -

Identifier Source: org_study_id