Effectiveness of ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Procedures
ASNG
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
1 other identifier
interventional
20
1 country
1
Brief Summary
To assist in guiding a rigid interventional instrument percutaneously, to a designated point within the body by means of CT visualization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedDecember 11, 2012
December 1, 2012
2.2 years
June 20, 2010
December 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of CT scans performed during the procedure, from needle insertion to final needle position in the target lesion
1 Hour- During the procedure
Secondary Outcomes (1)
Procedure time (needle dwell time in the body)
1 hour -duration of the procedure
Study Arms (1)
ActiSight Needle Guidance System
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ActiViews Ltd.lead
Study Sites (1)
Carmel Medical Center
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natan Peled, Dr.
Carmel MC
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2010
First Posted
June 22, 2010
Study Start
July 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
December 11, 2012
Record last verified: 2012-12