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

ActiViews

Status: Completed

Conditions: Biopsy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00814450

ASNG-LFNA-101-IL

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)