A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy With Lesions Smaller Than 15 mm
18 Years
N/A
Both
Cancer
Trial Information
A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy With Lesions Smaller Than 15 mm
Subjects who are scheduled for clinically indicated percutaneous chest aspiration/biopsy
procedures will be screened for inclusion in the study.
Within an 18-day screening period, eligible subjects will be enrolled into the study and
undergo percutaneous chest aspiration or percutaneous biopsy 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 the chest aspiration to
detect the majority of post procedure pneumothoraces. A follow-up visit will be conducted
within 7-10 days after the procedure day for safety evaluations.
Inclusion Criteria:
- Male or female subjects, 18 years of age or older at the time of enrollment
- Subjects scheduled for clinically indicated percutaneous chest aspiration/biopsy
procedures
- Subjects with lung lesions less than 15 mm.
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study procedures
Exclusion Criteria:
- Subjects who cannot tolerate mild sedation
- Subjects who participated in an active stage of any drug, intervention or treatment
trial within 30 days of enrollment.
- Subjects with preexisting conditions which, in the opinion of the investigator,
interfere with the conduct of the study.
- Subjects who are uncooperative or cannot follow instructions
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report
Outcome Description:
Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report
Outcome Time Frame:
6 month
Safety Issue:
No
Principal Investigator
Boaz Tiran, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tel-Aviv Sourasky Medical Center
Authority:
Israel: Ministry of Health
Study ID:
ASNG-LFNA-102-IL
NCT ID:
NCT01318473
Start Date:
June 2009
Completion Date:
January 2010
Related Keywords:
- Cancer
- cancer
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