CancerPhase 4ActiSightNCT01318473
The Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided With Lesions Smaller Than 15 mm
A Phase 4 study testing ActiSight™ Needle Guidance System in people with Cancer, run by ActiViews Ltd..
Trial summary
This will be a prospective, single-arm, single-center, open-label study to evaluate the use of the ActiSight™ Needle Guidance System in patients with lung lesions smaller than 15 mm undergoing CT-guided percutaneous chest aspiration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- ActiSight™ Needle Guidance System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jan 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18 years of age or older at the time of enrollment
- Subjects scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures
- Subjects with lung lesions less than 15 mm.
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study procedures
Who cannot join
- Subjects who cannot tolerate mild sedation
- Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
- Subjects with preexisting conditions which, in the opinion of the investigator, interfere with the conduct of the study.
- Subjects who are uncooperative or cannot follow instructions
About this study
Official title: A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy With Lesions Smaller Than 15 mm
This will be a prospective, single-arm, single-center, open-label study to evaluate the use of the ActiSight™ Needle Guidance System in patients with lung lesions smaller than 15 mm undergoing CT-guided percutaneous chest aspiration.
Target location will be in the chest area; the procedure will be performed by a trained physician.
Read the detailed description
Subjects who are scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures will be screened for inclusion in the study.
Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous chest aspiration or percutaneous biopsy utilizing the ActiSight™ Needle Guidance system using CT to guide the needle. Subjects will be followed-up for at least one hour at the clinic for safety and preliminary accuracy evaluations. An erect chest radiograph will be performed within 90 minutes of observation after the chest aspiration to detect the majority of post procedure pneumothoraces. A follow-up visit will be conducted within 7-10 days after the procedure day for safety evaluations.
- Conditions
- Cancer
- Being tested
- ActiSight™ Needle Guidance System
- Keywords
- cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiSight™ Needle Guidance SystemDevice
Also called ActiSight System
ActiSight™ Needle Guidance System is comprised of several sub-system components: a computer, a disposable ActiSensor optical sensor, and the disposable ActiSticker, which provides a reference for the insertion of the tool and for the camera.
| Study group | Role | What they receive |
|---|---|---|
| ActiSight™ Needle Guidance System | Other | ActiSight™ Needle Guidance System is comprised of several sub-system components: a computer, a disposable ActiSensor optical sensor, and the disposable ActiSticker, which provides a reference for the insertion of the tool and for the camera. Receives: Device: ActiSight™ Needle Guidance System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report
Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report
Measured: 6 month
Secondary outcomes (5)
Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images
Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images
Measured: 6 month
Number of needle punctures through the skin
Number of needle punctures through the skin
Measured: 6 month
Number of needle punctures through the pleura
Number of needle punctures through the pleura
Measured: 6 month
Number of CT scans needed
Number of CT scans needed
Measured: 6 month
Duration of procedure: patient preparation, planning, guidance and Cytolog report.
Duration of procedure: patient preparation, planning, guidance and Cytolog report.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startJun 2009
- Primary completionJan 2010
- Study completionJan 2010
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- ActiViews Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Responsible party
- Sponsor
- Investigators
- Boaz Tiran, Dr., Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318473
- Sponsor's protocol ID
- ASNG-LFNA-102-IL
- Other IDs
- ASNG-LFNA-101-IL
- Acronym
- ActiSight
- Status last verified
- Oct 2012
- First submitted
- 17 Mar 2011
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy With Lesions Smaller Than 15 mm
- ClinicalTrials.gov ID
- NCT01318473
- Acronym / sponsor ID
- ActiSight / ASNG-LFNA-102-IL
- Conditions
- Cancer
- Keywords
- cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- ActiViews Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Study start
- Jun 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 Mar 2011 (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.
This will be a prospective, single-arm, single-center, open-label study to evaluate the use of the ActiSight™ Needle Guidance System in patients with lung lesions smaller than 15 mm undergoing CT-guided percutaneous chest aspiration.
Target location will be in the chest area; the procedure will be performed by a trained physician.
Detailed description
Subjects who are scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures will be screened for inclusion in the study.
Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous chest aspiration or percutaneous biopsy utilizing the ActiSight™ Needle Guidance system using CT to guide the needle. Subjects will be followed-up for at least one hour at the clinic for safety and preliminary accuracy evaluations. An erect chest radiograph will be performed within 90 minutes of observation after the chest aspiration to detect the majority of post procedure pneumothoraces. A follow-up visit will be conducted within 7-10 days after the procedure day for safety evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ActiSight™ Needle Guidance System | Other | Device: ActiSight™ Needle Guidance SystemActiSight™ Needle Guidance System is comprised of several sub-system components: a computer, a disposable ActiSensor optical sensor, and the disposable ActiSticker, which provides a reference for the insertion of the tool and for the camera. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects, 18 years of age or older at the time of enrollment
- Subjects scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures
- Subjects with lung lesions less than 15 mm.
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study procedures
Key exclusion criteria (4 listed)
- Subjects who cannot tolerate mild sedation
- Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
- Subjects with preexisting conditions which, in the opinion of the investigator, interfere with the conduct of the study.
- Subjects who are uncooperative or cannot follow instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiSight™ Needle Guidance SystemAlso: ActiSight SystemActiSight™ Needle Guidance System is comprised of several sub-system components: a computer, a disposable ActiSensor optical sensor, and the disposable ActiSticker, which provides a reference for the insertion of the tool and for the camera. | Device | ActiSight™ Needle Guidance System |
Primary outcome
Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report
Time frame: 6 month
Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report
5 secondary outcomes
Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images
Time frame: 6 month
Number of needle punctures through the skin
Time frame: 6 month
Number of needle punctures through the pleura
Time frame: 6 month
Number of CT scans needed
Time frame: 6 month
Duration of procedure: patient preparation, planning, guidance and Cytolog report.
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
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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.
Boaz Tiran, Dr. principal investigator
Tel-Aviv Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ActiSight™ Needle Guidance System in people with Cancer, run by ActiViews 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 3 Oct 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report (time frame: 6 month). It is what the study was designed to measure, not a finding.
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 3 Oct 2012.