Lung DiseasesPhase 4ASNGNCT01148706
Effectiveness of ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Procedures
A Phase 4 study testing ActiSight Needle Guidance System in people with Lung Diseases and Liver Diseases, run by ActiViews Ltd. at 1 site in Israel.
Trial summary
To assist in guiding a rigid interventional instrument percutaneously, to a designated point within the body by means of CT visualization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Liver Diseases
- 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
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2010to Sep 2012
- 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 meeting all medical conditions for percutaneous CT guided. procedures in the chest, abdomen or pelvic, with safe path to lesion.
- Written informed consent to participate in the study.
- Ability to comply with the requirements of the study procedures.
Who cannot join
- Having co-morbidities that would clinically preclude them from an image guided procedure as determined by the operating physician.
- Significant coagulopathy that cannot be adequately corrected.
- Patients who have a medical contraindication to sedation (Lidocaine allergy).
- Pregnancy or lactation.
- Participation in an investigational trial within 30 days of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study of the ActiSight Needle Guidance System Which Assist in Guiding a Rigid Interventional Instrument Percutaneously, to a Designated Point Within the Body by Means of CT Visualization
To assist in guiding a rigid interventional instrument percutaneously, to a designated point within the body by means of CT visualization.
Read the detailed description
The ActiSight™ Needle Guidance System is an optical navigation system designed to assist physicians performing percutaneous interventions under CT guidance. The system allows the user to select an obstacle free path to a target lesion based on pre-procedure CT images, and then provides real-time information for guiding the interventional tool towards the target along the selected path.
The ActiSight™ Needle Guidance System employs a miniature video camera mounted on the needle and a reference pad attached to the skin to register the needle into the CT image space, and thus, track the needle advance towards the target. CT scans are used as needed to verify the location of the needle.
The primary objective of this study is to demonstrate the effectiveness of the ActiSight™ Needle Guidance System in assisting in CT-guided percutaneous procedures.
- Conditions
- Lung Diseases, Liver Diseases
- Being tested
- ActiSight Needle Guidance System
- Keywords
- thorax, abdomen
- Medical subject headings
- Lung Diseases, Liver Diseases
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 ASNG=ActiSight Needle Guidance System
The ActiSight™ Needle Guidance System employs a miniature video camera mounted on the needle and a reference pad attached to the skin to register the needle into the CT image space, and thus, track the needle advance towards the target. CT scans are used as needed to verify the location of the needle.
| Study group | Role | What they receive |
|---|---|---|
| ActiSight Needle Guidance System | Experimental | Not described Receives: Device: ActiSight Needle Guidance System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CT scans performed during the procedure, from needle insertion to final needle position in the target lesion
Measured: 1 Hour- During the procedure
Secondary outcomes (1)
Procedure time (needle dwell time in the body)
Measured: 1 hour -duration of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ActiViews Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natan Peled, Dr., Principal investigator, Carmel MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148706
- Sponsor's protocol ID
- ASNG-LFNA-103-IL
- Acronym
- ASNG
- Status last verified
- Dec 2012
- First submitted
- 20 Jun 2010
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of the ActiSight Needle Guidance System Which Assist in Guiding a Rigid Interventional Instrument Percutaneously, to a Designated Point Within the Body by Means of CT Visualization
- ClinicalTrials.gov ID
- NCT01148706
- Acronym / sponsor ID
- ASNG / ASNG-LFNA-103-IL
- Conditions
- Lung Diseases, Liver Diseases
- Keywords
- thorax, abdomen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ActiViews Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Jun 2010 (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.
To assist in guiding a rigid interventional instrument percutaneously, to a designated point within the body by means of CT visualization.
Detailed description
The ActiSight™ Needle Guidance System is an optical navigation system designed to assist physicians performing percutaneous interventions under CT guidance. The system allows the user to select an obstacle free path to a target lesion based on pre-procedure CT images, and then provides real-time information for guiding the interventional tool towards the target along the selected path.
The ActiSight™ Needle Guidance System employs a miniature video camera mounted on the needle and a reference pad attached to the skin to register the needle into the CT image space, and thus, track the needle advance towards the target. CT scans are used as needed to verify the location of the needle.
The primary objective of this study is to demonstrate the effectiveness of the ActiSight™ Needle Guidance System in assisting in CT-guided percutaneous procedures.
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 | Experimental | Device: 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 (4 listed)
- Male or female subjects, 18 years of age or older at the time of enrollment.
- Subjects meeting all medical conditions for percutaneous CT guided. procedures in the chest, abdomen or pelvic, with safe path to lesion.
- Written informed consent to participate in the study.
- Ability to comply with the requirements of the study procedures.
Key exclusion criteria (5 listed)
- Having co-morbidities that would clinically preclude them from an image guided procedure as determined by the operating physician.
- Significant coagulopathy that cannot be adequately corrected.
- Patients who have a medical contraindication to sedation (Lidocaine allergy).
- Pregnancy or lactation.
- Participation in an investigational trial within 30 days of enrollment.
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: ASNG=ActiSight Needle Guidance SystemThe ActiSight™ Needle Guidance System employs a miniature video camera mounted on the needle and a reference pad attached to the skin to register the needle into the CT image space, and thus, track the needle advance towards the target. CT scans are used as needed to verify the location of the needle. | Device | ActiSight Needle Guidance System |
Primary outcome
Number of CT scans performed during the procedure, from needle insertion to final needle position in the target lesion
Time frame: 1 Hour- During the procedure
1 secondary outcome
Procedure time (needle dwell time in the body)
Time frame: 1 hour -duration of the procedure
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 11 Dec 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.
Natan Peled, Dr. principal investigator
Carmel MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ActiSight Needle Guidance System in people with Lung Diseases and Liver Diseases, run by ActiViews Ltd. at 1 site in Israel.
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 4 inclusion and 5 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 11 Dec 2012. 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 Israel. 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.
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?
Number of CT scans performed during the procedure, from needle insertion to final needle position in the target lesion (time frame: 1 Hour- During the procedure). 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 11 Dec 2012.