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

Biopsy Clinical Trial

— ANGS-PCAB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814450
• Other study ID #: ASNG-LFNA-101-IL
• Status: Completed
• Phase: N/A
• First received: December 23, 2008
• Last updated: December 29, 2009
• Start date: December 2008
• Est. completion date: June 2009

Study information

• Verified date: December 2009
• Source: ActiViews Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Biopsy

Intervention

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.

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
ActiViews Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of needle punctures through the skin		Measure evaluated during entire course of study	No
Secondary	Number of needle punctures through the pleura		Measure evaluated during entire course of study	No
Secondary	Number of CT scans needed		Measure evaluated during entire course of study	No
Secondary	Radial distance at target plane at the needle's final position as shown on the ActiSight screen		Measure evaluated during entire course of study	No
Secondary	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	Yes