Safety & Accuracy of the ActiSight Needle Guidance System in Percutaneous Chest Aspiration and Biopsy (ANGS-PCAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00814450
Recruitment Status : Completed
First Posted : December 24, 2008
Last Update Posted : December 30, 2009
Information provided by:
ActiViews Ltd.

Brief Summary:
This study is intended to provide clinical data regarding safety and accuracy of the ActiSight™ Needle Guidance System in assisting Chest CT guided biopsies.

Condition or disease Intervention/treatment Phase
Biopsy Device: Biopsy needle guidance system (ActiSight™) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Chest Aspiration And Biopsy
Study Start Date : December 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Intervention Details:
    Device: Biopsy needle guidance system (ActiSight™)
    The ActiSight system assists in guiding an aspiration or biopsy needle, to a designated point within the body by means of CT visualization.

Primary Outcome Measures :
  1. Frequency of target reached within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan. [ Time Frame: Measure evaluated during entire course of study ]

Secondary Outcome Measures :
  1. Number of needle punctures through the skin [ Time Frame: Measure evaluated during entire course of study ]
  2. Number of needle punctures through the pleura [ Time Frame: Measure evaluated during entire course of study ]
  3. Number of CT scans needed [ Time Frame: Measure evaluated during entire course of study ]
  4. Radial distance at target plane at the needle's final position as shown on the ActiSight screen [ Time Frame: Measure evaluated during entire course of study ]
  5. Adverse events following the procedure, including the following:Pneumothorax, Hemoptysis >100 ml, Bleeding, Collapsed lung, Chest drainage, Need for hospitalization [ Time Frame: Measure evaluated during entire course of study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subjects, 18 years of age or older at the time of enrollment
  • Subjects meeting all medical conditions for percutaneous chest aspiration/biopsy with safe path to lesion between ribs, however, not in the breast area in women or men with gynecomastia
  • Single target pulmonary lesion greater than 10 mm in size (diameter) and depth of lesion greater than 40 mm from the skin
  • INR <1.3
  • Written informed consent to participate in the study
  • Ability to comply with the requirements of the study procedures

Exclusion Criteria:

  • Fibrous tissue or cyst in access path (not including target lesion)
  • Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
  • Central lesion is located in radius of less than 2 cm from lobar blood vessels and the heart.
  • The selected needle path has a safety margin of less than 2 cm from major blood vessels and the heart
  • Use of ticlopidine or similar antithrombotic medication
  • For subjects taking warfarin or other anticoagulant medication, INR >1.3
  • Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
  • Subjects who cannot tolerate mild sedation
  • Subjects with FEV1 < 800 mL unless approved by principal investigator following consultation with multidisciplinary team
  • Subjects with the following laboratory values, unless approved by hematologist:

    • Platelet count <100,000/mL
    • APTT >39 sec or PT >15 sec
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00814450

Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
ActiViews Ltd.
Principal Investigator: Boaz Tiran, MD Tel-Aviv Sourasky Medical Center

Responsible Party: Uri Shreter/ Medical Director, Activiews Identifier: NCT00814450     History of Changes
Other Study ID Numbers: ASNG-LFNA-101-IL
First Posted: December 24, 2008    Key Record Dates
Last Update Posted: December 30, 2009
Last Verified: December 2009

Keywords provided by ActiViews Ltd.:
Fine needle aspiration