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

This study has been completed.
Sponsor:
Information provided by:
ActiViews Ltd.
ClinicalTrials.gov Identifier:
NCT00814450
First received: December 23, 2008
Last updated: December 29, 2009
Last verified: December 2009
  Purpose

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 Intervention
Biopsy
Device: Biopsy needle guidance system (ActiSight™)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ActiViews Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of needle punctures through the skin [ Time Frame: Measure evaluated during entire course of study ] [ Designated as safety issue: No ]
  • Number of needle punctures through the pleura [ Time Frame: Measure evaluated during entire course of study ] [ Designated as safety issue: No ]
  • Number of CT scans needed [ Time Frame: Measure evaluated during entire course of study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: December 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814450

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

No publications provided

Responsible Party: Uri Shreter/ Medical Director, Activiews
ClinicalTrials.gov Identifier: NCT00814450     History of Changes
Other Study ID Numbers: ASNG-LFNA-101-IL
Study First Received: December 23, 2008
Last Updated: December 29, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by ActiViews Ltd.:
Biopsy
Fine needle aspiration

ClinicalTrials.gov processed this record on July 20, 2014