CancerNCT00791609
Evaluation the Feasibility of the FOSTI Device
An observational study of Cancer, run by Optivasive Ltd..
Trial summary
Feasibility of accurate differentiation between malignant and benign tissue using the FOSTI device on surgically removed tissue Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cancer
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will consist of subjects who undergo cancer surgery
Who may be able to join
- Subjects of all ages.
- Subject is able, agree and sign the Informed Consent Form.
Who cannot join
- Subject has any conditions, which precludes compliance with study
About this study
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
Feasibility of accurate differentiation between malignant and benign tissue using the FOSTI device on surgically removed tissue
Read the 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.
- Conditions
- Cancer
- Keywords
- cancer
- Medical subject headings
- Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optivasive Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anatoliy Babchenko, Study director, Optivasive Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791609
- Sponsor's protocol ID
- OpVe-HI-08-001
- Status last verified
- Nov 2008
- First submitted
- 13 Nov 2008
- Last updated
- 14 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00791609
- Acronym / sponsor ID
- OpVe-HI-08-001
- Conditions
- Cancer
- Keywords
- cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Optivasive Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- First posted
- 14 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility of accurate differentiation between malignant and benign tissue using the FOSTI device on surgically removed tissue
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of subjects who undergo cancer surgery
Key inclusion criteria (2 listed)
- Subjects of all ages.
- Subject is able, agree and sign the Informed Consent Form.
Key exclusion criteria (1 listed)
- Subject has any conditions, which precludes compliance with study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anatoliy Babchenko study director
Optivasive Ltd.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Optivasive Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2008; AzTrials last refreshed its copy on 7 Nov 2026.