Accurate Navigation to the LesionPhase 4NCT01367392
Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance System
A Phase 4 study testing biopsy or ablation in people with Accurate Navigation to the Lesion, run by ActiViews Ltd. at 1 site in Canada.
Trial summary
The purpose of this study is to confirm the safety and effectiveness of the ActiSight™ Needle Guidance System with CT-guided percutaneous (through the skin) liver biopsies and ablations . The device used in this study is designed to assist the physician in guiding the needle towards the suspected area. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Accurate Navigation to the Lesion
- What is being tested?
- biopsy or ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Jan 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment.
- Subjects scheduled for clinically indicated CT guided percutaneous needle placements in the liver who meet the desired target population described above.
- Written informed consent to participate in the study.
- Ability to comply with the requirements of the study procedures.
- Verified home address and phone number to facilitate study follow-up.
Who cannot join
- Significant coagulopathy that cannot be adequately corrected.
- 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.
- Mental state that may preclude completion of the study procedure.
- Pregnant or nursing female subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Confirmation of Clinical Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance System
The purpose of this study is to confirm the safety and effectiveness of the ActiSight™ Needle Guidance System with CT-guided percutaneous (through the skin) liver biopsies and ablations . The device used in this study is designed to assist the physician in guiding the needle towards the suspected area. This device does not change the procedure of liver biopsy or ablation. The only difference is that a small adhesive pad is placed on the skin and a miniature video camera is attached to the end of the needle. This camera does not enter the body.
- Conditions
- Accurate Navigation to the Lesion
- Being tested
- biopsy or ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy or ablationDevice
biopsy or ablation performed as in standard of care with assistance of ActiSight Needle Guidance system
| Study group | Role | What they receive |
|---|---|---|
| interventional procedure | Experimental | The patients undergo the required interventional procedure, biopsy or ablation Receives: Device: biopsy or ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy
Frequency of placing the needle at a location suitable for the planned intervention, as determined by the investigator reviewing the CT images.
Measured: during the procedure
Secondary outcomes (4)
time
Total CT-Guided procedure time, starting with scan for entry point planning;
Measured: during the procedure
time
Time required to guide the needle to the target
Measured: during the procedure
radiation
Subject radiation exposure during the procedure
Measured: during the procedure
total number of scans
Number of CT scans during the procedure
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accurate Navigation to the LesionStudies 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
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367392
- Sponsor's protocol ID
- ACST-2011-1
- Status last verified
- Feb 2012
- First submitted
- 6 Jun 2011
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmation of Clinical Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance System
- ClinicalTrials.gov ID
- NCT01367392
- Acronym / sponsor ID
- ACST-2011-1
- Conditions
- Accurate Navigation to the Lesion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ActiViews Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 7 Jun 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.
The purpose of this study is to confirm the safety and effectiveness of the ActiSight™ Needle Guidance System with CT-guided percutaneous (through the skin) liver biopsies and ablations . The device used in this study is designed to assist the physician in guiding the needle towards the suspected area. This device does not change the procedure of liver biopsy or ablation. The only difference is that a small adhesive pad is placed on the skin and a miniature video camera is attached to the end of the needle. This camera does not enter the body.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional procedure | Experimental | Device: biopsy or ablationThe patients undergo the required interventional procedure, biopsy or ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment.
- Subjects scheduled for clinically indicated CT guided percutaneous needle placements in the liver who meet the desired target population described above.
- Written informed consent to participate in the study.
- Ability to comply with the requirements of the study procedures.
- Verified home address and phone number to facilitate study follow-up.
Key exclusion criteria (6 listed)
- Significant coagulopathy that cannot be adequately corrected.
- 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.
- Mental state that may preclude completion of the study procedure.
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 |
|---|---|---|
| biopsy or ablationbiopsy or ablation performed as in standard of care with assistance of ActiSight Needle Guidance system | Device | interventional procedure |
Primary outcome
accuracy
Time frame: during the procedure
Frequency of placing the needle at a location suitable for the planned intervention, as determined by the investigator reviewing the CT images.
4 secondary outcomes
time
Time frame: during the procedure
time
Time frame: during the procedure
radiation
Time frame: during the procedure
total number of scans
Time frame: during 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 15 Feb 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 biopsy or ablation in people with Accurate Navigation to the Lesion, 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 6 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 15 Feb 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 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.
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?
accuracy (time frame: 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 15 Feb 2012.