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
18 Years
N/A
Both
Cancer
Trial Information
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
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Outcome Time Frame:
During procedure
Safety Issue:
No
Principal Investigator
Liat Appelbaum, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hadassah Ein Carem
Authority:
Israel: Ministry of Health
Study ID:
ASNG-LFNA-101-IL-H
NCT ID:
NCT01040884
Start Date:
June 2010
Completion Date:
January 2012
Related Keywords:
- Cancer
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