CancerPhase 4NCT01040884
Safety And Accuracy Study Of The Actisight™ Needle Guidance System In Patients Undergoing CT-Guided Procedures
A Phase 4 study testing ActiSight Needle Guidance System in people with Cancer, run by ActiViews Ltd. at 1 site in Israel.
Trial summary
This will be a prospective, single-arm, single-center, open-label study to evaluate the preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients undergoing CT-guided percutaneous aspiration and RF Ablations The procedure will be performed by a trained physician. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to 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 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 aspiration/biopsy with safe path to lesion
- INR <1.4
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study procedures
Who cannot join
- Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
- Use of Aspirin or similar antithrombotic medication
- Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
- Subjects who cannot tolerate mild sedation
- Subjects with the following laboratory values, unless approved by hematologist:
- Platelet count < 60,000/mL
Show all 12Show fewer
- APTT > 39 sec or PT > 15 sec, INR > 1.4
- 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 Aspiration, Biopsy and RF Ablations
This will be a prospective, single-arm, single-center, open-label study to evaluate the preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients undergoing CT-guided percutaneous aspiration and RF Ablations The procedure will be performed by a trained physician. Subjects will be screened for inclusion in the study. Following signing of informed consent, screening procedures will be performed including demographic and medical history, vital signs, anthropometrics), chest radiography, if applicable and CT scanning, blood samples for coagulation indices (PT, APTT), if applicable, and pregnancy test in women of child-bearing potential.
Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation 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 chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. Note If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.
Read the detailed description
Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation 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 chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. Note If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.
- Conditions
- Cancer
- Being tested
- ActiSight Needle Guidance System
- 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 SystemOther
Also called ActiSensor, ActiSticker
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 | Experimental | 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: Other: 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 (tip of the needle location) within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan
Measured: During procedure
Secondary outcomes (2)
Number of needle punctures through the skin
Measured: During procedure
Number of CT scans needed
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2009 (estimated)
- Study startJun 2010
- 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 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ActiViews Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liat Appelbaum, Dr., Principal investigator, Hadassah Ein Carem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040884
- Sponsor's protocol ID
- ASNG-LFNA-101-IL-H
- Status last verified
- Jul 2012
- First submitted
- 29 Dec 2009
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 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 Preliminary Safety and Accuracy of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Aspiration, Biopsy and RF Ablations
- ClinicalTrials.gov ID
- NCT01040884
- Acronym / sponsor ID
- ASNG-LFNA-101-IL-H
- Conditions
- Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ActiViews Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 30 Dec 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 will be a prospective, single-arm, single-center, open-label study to evaluate the preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients undergoing CT-guided percutaneous aspiration and RF Ablations The procedure will be performed by a trained physician. Subjects will be screened for inclusion in the study. Following signing of informed consent, screening procedures will be performed including demographic and medical history, vital signs, anthropometrics), chest radiography, if applicable and CT scanning, blood samples for coagulation indices (PT, APTT), if applicable, and pregnancy test in women of child-bearing potential.
Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation 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 chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. Note If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.
Detailed description
Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation 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 chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. Note If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.
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 | Other: 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 meeting all medical conditions for percutaneous aspiration/biopsy with safe path to lesion
- INR <1.4
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study procedures
Key exclusion criteria (12 listed)
- Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
- Use of Aspirin or similar antithrombotic medication
- Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
- Subjects who cannot tolerate mild sedation
- Subjects with the following laboratory values, unless approved by hematologist:
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: ActiSensor, ActiStickerActiSight™ 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 | Other | ActiSight Needle Guidance System |
Primary outcome
Frequency of target reached (tip of the needle location) within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan
Time frame: During procedure
2 secondary outcomes
Number of needle punctures through the skin
Time frame: During procedure
Number of CT scans needed
Time frame: During 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 12 Jul 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.
Liat Appelbaum, Dr. principal investigator
Hadassah Ein Carem
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 Cancer, 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 5 inclusion and 12 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 12 Jul 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?
Frequency of target reached (tip of the needle location) within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan (time frame: During 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 12 Jul 2012.