BiopsyNCT00819533
Safety & Accuracy Study of the ActiSight Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy
A study testing sensor (ActiSight™ Needle Guidance System) in people with Biopsy, run by ActiViews Ltd. at 1 site in Canada.
Trial summary
This study is designed to evaluate preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients undergoing CT-guided lung aspiration or biopsy. This image guidance system uses a combination of CT scans and camera images to help guide a biopsy needle to a lung lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biopsy
- What is being tested?
- sensor (ActiSight™ Needle Guidance System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Oct 2009
- Phase
- Interventional
- 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 meeting all medical conditions for percutaneous chest aspiration/biopsy with safe path to lesion between ribs, however, not in the breast area in women or men with gynecomastia
- Single target pulmonary lesion greater than 10 mm in size (diameter) and depth of lesion greater than 40 mm from the skin
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study procedures
Who cannot join
- Fibrous tissue or cyst in access path (not including target lesion)
- Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
- Use of ticlodipine or similar antithrombotic medication
- For subjects taking warfarin or other anticoagulant medication, INR >1.3
- Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
- Patient is unable to comply with requirements of the procedure, i.e. holding breath
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- Participation in any prior investigational trial within 30 days of enrollment
- Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder, or any chronic condition that could, in the opinion of the investigator, of interfering with the conduct of the study.
- Subjects who are uncooperative or cannot follow instructions
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Toronto General Hospital
Toronto, Ontario
About this study
Official title: A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Preliminary Safety and Accuracy of the ActiSight Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy
This study is designed to evaluate preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients undergoing CT-guided lung aspiration or biopsy. This image guidance system uses a combination of CT scans and camera images to help guide a biopsy needle to a lung lesion. The system displays a simulated image of a biopsy needle and its estimated path for the biopsy.
Read the detailed description
Why is this study conducted to demonstrate the safety and effectiveness of the ActiSight Needle Guidance System in assisting trained physicians perform CT guided percutaneous needle biopsy (PNB) and fine needle aspiration (FNA) procedures in the chest.
Subjects, who are scheduled for medically indicated chest PNB or FNA procedures and meet all the inclusion and exclusion criteria, will be asked to participate in the study. The aim is to enroll 40 subjects that will complete the whole study.
Recruited subjects will go through screening tests and if eligible, will undergo, within 18 days of screening, CT Guided chest PNB or FNA utilizing the ActiSight Needle Guidance system. Subjects will be observed and tested for at least an hour after the procedure to detect any serious complications. A follow-up will be conducted within 7-10 days after the procedure day for safety evaluations. Safety and accuracy data from all stages of the study will be collected and analyzed.
The effectiveness of the guidance system will be measured primarily by the frequency of reaching the intended targets, as determined by a final CT scan. Other measures will include the number of needle punctures and the number of intermediate CT scans needed to complete the procedure. The safety of the system will be measured by the frequency and severity of adverse events.
Procedure description:
First, a single-use, disposable pad (ActiSticker) is attached to the patient's skin over the point of needle insertion as selected by the interventionist. The pad incorporates reference objects that are easily detectable both on CT images and visually. A volume CT scan, covering at least the pad, the target lesion and adjacent structures is then performed. Next, the CT images from the volume scan are transferred to the ActiSight computer where the operator marks the target of the procedure, as well as all the reference points on the ActiSticker. Next, an optical sensor, also single-use and disposable, is attached to the top of the needle. By optically detecting all the reference points and relating them to their known positions on the CT images, the system can calculate the position of the top and the tip of the needle with relation to the target lesion. During the procedure, the system shows the user, on a graphic computer display, whether the needle is aimed directly at the target and how far the tip of the needle is from the intended target to help the user aim the insertion and guidance of the needle to the target.
- Conditions
- Biopsy
- Being tested
- sensor (ActiSight™ Needle Guidance System)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensor (ActiSight™ Needle Guidance System)Device
Patients will have their lung sample obtained under CT and ActiSight needle guidance system
| Study group | Role | What they receive |
|---|---|---|
| sensor | Experimental | Patients will have their lung sample obtained under CT and ActiSight needle guidance system Receives: Device: sensor (ActiSight™ Needle Guidance System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of target reached within a radius of 5 mm from the preplanned targeted point as measured on the final CT scan
Measured: Measure evaluated during entire course of study
Secondary outcomes (3)
Number of punctures required to obtain sample
Measured: Measure evaluated during entire course of study
Number of intermediate CT scans required to obtain sample
Measured: During entire course of study
An adequate sample obtained during the procedure
Measured: during entire course of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJan 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiopsyStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ActiViews Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Narinder Paul, MD, Principal investigator, University Health Network, Toronto General HospitalUri Shreter, Ph.D., Study director, ActiViews Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819533
- Sponsor's protocol ID
- ASNG-LFNA-101-CAN
- Status last verified
- Dec 2009
- First submitted
- 8 Jan 2009
- Last updated
- 29 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2009. 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 Preliminary Safety and Accuracy of the ActiSight Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy
- ClinicalTrials.gov ID
- NCT00819533
- Acronym / sponsor ID
- ASNG-LFNA-101-CAN
- Conditions
- Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ActiViews Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 9 Jan 2009 (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 study is designed to evaluate preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients undergoing CT-guided lung aspiration or biopsy. This image guidance system uses a combination of CT scans and camera images to help guide a biopsy needle to a lung lesion. The system displays a simulated image of a biopsy needle and its estimated path for the biopsy.
Detailed description
Why is this study conducted to demonstrate the safety and effectiveness of the ActiSight Needle Guidance System in assisting trained physicians perform CT guided percutaneous needle biopsy (PNB) and fine needle aspiration (FNA) procedures in the chest.
Subjects, who are scheduled for medically indicated chest PNB or FNA procedures and meet all the inclusion and exclusion criteria, will be asked to participate in the study. The aim is to enroll 40 subjects that will complete the whole study.
Recruited subjects will go through screening tests and if eligible, will undergo, within 18 days of screening, CT Guided chest PNB or FNA utilizing the ActiSight Needle Guidance system. Subjects will be observed and tested for at least an hour after the procedure to detect any serious complications. A follow-up will be conducted within 7-10 days after the procedure day for safety evaluations. Safety and accuracy data from all stages of the study will be collected and analyzed.
The effectiveness of the guidance system will be measured primarily by the frequency of reaching the intended targets, as determined by a final CT scan. Other measures will include the number of needle punctures and the number of intermediate CT scans needed to complete the procedure. The safety of the system will be measured by the frequency and severity of adverse events.
Procedure description:
First, a single-use, disposable pad (ActiSticker) is attached to the patient's skin over the point of needle insertion as selected by the interventionist. The pad incorporates reference objects that are easily detectable both on CT images and visually. A volume CT scan, covering at least the pad, the target lesion and adjacent structures is then performed. Next, the CT images from the volume scan are transferred to the ActiSight computer where the operator marks the target of the procedure, as well as all the reference points on the ActiSticker. Next, an optical sensor, also single-use and disposable, is attached to the top of the needle. By optically detecting all the reference points and relating them to their known positions on the CT images, the system can calculate the position of the top and the tip of the needle with relation to the target lesion. During the procedure, the system shows the user, on a graphic computer display, whether the needle is aimed directly at the target and how far the tip of the needle is from the intended target to help the user aim the insertion and guidance of the needle to the target.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sensor | Experimental | Device: sensor (ActiSight™ Needle Guidance System)Patients will have their lung sample obtained under CT and ActiSight needle guidance system |
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 meeting all medical conditions for percutaneous chest aspiration/biopsy with safe path to lesion between ribs, however, not in the breast area in women or men with gynecomastia
- Single target pulmonary lesion greater than 10 mm in size (diameter) and depth of lesion greater than 40 mm from the skin
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study procedures
Key exclusion criteria (9 listed)
- Fibrous tissue or cyst in access path (not including target lesion)
- Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
- Use of ticlodipine or similar antithrombotic medication
- For subjects taking warfarin or other anticoagulant medication, INR >1.3
- Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
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 |
|---|---|---|
| sensor (ActiSight™ Needle Guidance System)Patients will have their lung sample obtained under CT and ActiSight needle guidance system | Device | sensor |
Primary outcome
Frequency of target reached within a radius of 5 mm from the preplanned targeted point as measured on the final CT scan
Time frame: Measure evaluated during entire course of study
3 secondary outcomes
Number of punctures required to obtain sample
Time frame: Measure evaluated during entire course of study
Number of intermediate CT scans required to obtain sample
Time frame: During entire course of study
An adequate sample obtained during the procedure
Time frame: during entire course of study
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 29 Dec 2009.
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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.
Narinder Paul, MD principal investigator
University Health Network, Toronto General Hospital
Uri Shreter, Ph.D. study director
ActiViews Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensor (ActiSight™ Needle Guidance System) in people with Biopsy, run by ActiViews Ltd. at 1 site in Canada.
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 9 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 29 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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 target reached within a radius of 5 mm from the preplanned targeted point as measured on the final CT scan (time frame: Measure evaluated during entire course of study). 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 29 Dec 2009.