Back to resultsEffectiveness of ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Procedures (ASNG)
Primary Purpose
Lung Diseases, Liver Diseases
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
ActiSight Needle Guidance System
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases focused on measuring thorax, abdomen
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Carmel Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ActiSight Needle Guidance System
Arm Description
Outcomes
Primary Outcome Measures
Number of CT scans performed during the procedure, from needle insertion to final needle position in the target lesion
Secondary Outcome Measures
Procedure time (needle dwell time in the body)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01148706
Brief Title
Effectiveness of ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Procedures
Acronym
ASNG
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ActiViews Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Liver Diseases
Keywords
thorax, abdomen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ActiSight Needle Guidance System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ActiSight Needle Guidance System
Other Intervention Name(s)
ASNG=ActiSight Needle Guidance System
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Procedure time (needle dwell time in the body)
Time Frame
1 hour -duration of the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natan Peled, Dr.
Organizational Affiliation
Carmel MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Procedures
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