NCT01318473

The Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided With Lesions Smaller Than 15 mm

A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy With Lesions Smaller Than 15 mm

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: ActiViews Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a prospective, single-arm, single-center, open-label study to evaluate the use of the ActiSight™ Needle Guidance System in patients with lung lesions smaller than 15 mm undergoing CT-guided percutaneous chest aspiration. Target location will be in the chest area; the procedure will be performed by a trained physician.

Detailed description

Subjects who are scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures will be screened for inclusion in the study. Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous chest aspiration or percutaneous biopsy utilizing the ActiSight™ Needle Guidance system using CT to guide the needle. Subjects will be followed-up for at least one hour at the clinic for safety and preliminary accuracy evaluations. An erect chest radiograph will be performed within 90 minutes of observation after the chest aspiration to detect the majority of post procedure pneumothoraces. A follow-up visit will be conducted within 7-10 days after the procedure day for safety evaluations.

Conditions

• Cancer

Interventions

Type	Name	Description
DEVICE	ActiSight™ Needle Guidance System	ActiSight™ Needle Guidance System is comprised of several sub-system components: a computer, a disposable ActiSensor optical sensor, and the disposable ActiSticker, which provides a reference for the insertion of the tool and for the camera.

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2011-03-18
• Last updated: 2012-10-03