Safety & Accuracy of the ActiSight Needle Guidance System in Percutaneous Chest Aspiration and Biopsy

NCT00814450 | Completed

• 1 other identifier: ASNG-LFNA-101-IL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Biopsy

Keywords

Biopsy; Fine needle aspiration

Outcome Measures

Primary Outcomes (1)

• Frequency of target reached within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan.

  Measure evaluated during entire course of study

Secondary Outcomes (5)

• Number of needle punctures through the skin

  Measure evaluated during entire course of study

• Number of needle punctures through the pleura

  Measure evaluated during entire course of study

• Number of CT scans needed

  Measure evaluated during entire course of study

• Radial distance at target plane at the needle's final position as shown on the ActiSight screen

  Measure evaluated during entire course of study

• Adverse events following the procedure, including the following:Pneumothorax, Hemoptysis >100 ml, Bleeding, Collapsed lung, Chest drainage, Need for hospitalization

  Measure evaluated during entire course of study

Interventions

Biopsy needle guidance system (ActiSight™) DEVICE

The ActiSight system assists in guiding an aspiration or biopsy needle, to a designated point within the body by means of CT visualization.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ActiViews Ltd.: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Study Officials

• Boaz Tiran, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 24, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 30, 2009

Record last verified: 2009-12

Locations

IL (1)