BiopsyANGS-PCABNCT00814450
Safety & Accuracy of the ActiSight Needle Guidance System in Percutaneous Chest Aspiration and Biopsy
A study testing Biopsy needle guidance system (ActiSight™) in people with Biopsy, run by ActiViews Ltd. at 1 site in Israel.
Trial summary
This study is intended to provide clinical data regarding safety and accuracy of the ActiSight™ Needle Guidance System in assisting Chest CT guided biopsies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biopsy
- What is being tested?
- Biopsy needle guidance system (ActiSight™)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Jun 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
- INR <1.3
- 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
- Central lesion is located in radius of less than 2 cm from lobar blood vessels and the heart.
- The selected needle path has a safety margin of less than 2 cm from major blood vessels and the heart
- Use of ticlopidine or similar antithrombotic medication
- For subjects taking warfarin or other anticoagulant medication, INR >1.3
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- Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
- Subjects who cannot tolerate mild sedation
- Subjects with FEV1 < 800 mL unless approved by principal investigator following consultation with multidisciplinary team
- Subjects with the following laboratory values, unless approved by hematologist:
- Platelet count <100,000/mL
- APTT >39 sec or PT >15 sec
- Pregnancy or lactation
- Patient is unable to comply with requirements of the procedure, i.e. holding breath
- Participation in an 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.
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 intended to provide clinical data regarding safety and accuracy of the ActiSight™ Needle Guidance System in assisting Chest CT guided biopsies.
- Conditions
- Biopsy
- Being tested
- Biopsy needle guidance system (ActiSight™)
- Keywords
- Biopsy, Fine needle aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy needle guidance system (ActiSight™)Device
The ActiSight system assists in guiding an aspiration or biopsy needle, to a designated point within the body by means of CT visualization.
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 8 mm from the preplanned targeted point as measured on the final CT scan.
Measured: Measure evaluated during entire course of study
Secondary outcomes (5)
Number of needle punctures through the skin
Measured: Measure evaluated during entire course of study
Number of needle punctures through the pleura
Measured: Measure evaluated during entire course of study
Number of CT scans needed
Measured: Measure evaluated during entire course of study
Radial distance at target plane at the needle's final position as shown on the ActiSight screen
Measured: Measure evaluated during entire course of study
Adverse events following the procedure, including the following:Pneumothorax, Hemoptysis >100 ml, Bleeding, Collapsed lung, Chest drainage, Need for hospitalization
Measured: Measure evaluated 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 posted24 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionJun 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ActiViews Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boaz Tiran, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814450
- Sponsor's protocol ID
- ASNG-LFNA-101-IL
- Acronym
- ANGS-PCAB
- Status last verified
- Dec 2009
- First submitted
- 23 Dec 2008
- Last updated
- 30 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 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
- NCT00814450
- Acronym / sponsor ID
- ANGS-PCAB / ASNG-LFNA-101-IL
- Conditions
- Biopsy
- Keywords
- Biopsy, Fine needle aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ActiViews Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Dec 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.
This study is intended to provide clinical data regarding safety and accuracy of the ActiSight™ Needle Guidance System in assisting Chest CT guided biopsies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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
- INR <1.3
- Written informed consent to participate in the study
Key exclusion criteria (17 listed)
- Fibrous tissue or cyst in access path (not including target lesion)
- Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
- Central lesion is located in radius of less than 2 cm from lobar blood vessels and the heart.
- The selected needle path has a safety margin of less than 2 cm from major blood vessels and the heart
- Use of ticlopidine or similar antithrombotic medication
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 needle guidance system (ActiSight™)The ActiSight system assists in guiding an aspiration or biopsy needle, to a designated point within the body by means of CT visualization. | Device | – |
Primary outcome
Frequency of target reached within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan.
Time frame: Measure evaluated during entire course of study
5 secondary outcomes
Number of needle punctures through the skin
Time frame: Measure evaluated during entire course of study
Number of needle punctures through the pleura
Time frame: Measure evaluated during entire course of study
Number of CT scans needed
Time frame: Measure evaluated during entire course of study
Radial distance at target plane at the needle's final position as shown on the ActiSight screen
Time frame: Measure evaluated during entire course of study
Adverse events following the procedure, including the following:Pneumothorax, Hemoptysis >100 ml, Bleeding, Collapsed lung, Chest drainage, Need for hospitalization
Time frame: Measure evaluated 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 30 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.
Boaz Tiran, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy needle guidance system (ActiSight™) in people with Biopsy, 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 6 inclusion and 17 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 30 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 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.
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 8 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 30 Dec 2009.