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

Cancer Clinical Trial

— ActiSight  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318473
• Other study ID #: ASNG-LFNA-102-IL
• Secondary ID: ASNG-LFNA-101-IL
• Status: Completed
• Phase: Phase 4
• First received: March 17, 2011
• Last updated: October 2, 2012
• Start date: June 2009
• Est. completion date: January 2010

Study information

• Verified date: October 2012
• Source: ActiViews Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• 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 scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures

• Subjects with lung lesions less than 15 mm.

• Written informed consent to participate in the study

• Ability to comply with the requirements of the study procedures

Exclusion Criteria:

• Subjects who cannot tolerate mild sedation

• Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.

• Subjects with preexisting conditions which, in the opinion of the investigator, interfere with the conduct of the study.

• Subjects who are uncooperative or cannot follow instructions

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ActiViews Ltd.	Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report	Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report	6 month	No
Secondary	Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images	Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images	6 month	No
Secondary	Number of needle punctures through the skin	Number of needle punctures through the skin	6 month	No
Secondary	Number of needle punctures through the pleura	Number of needle punctures through the pleura	6 month	No
Secondary	Number of CT scans needed	Number of CT scans needed	6 month	No
Secondary	Duration of procedure: patient preparation, planning, guidance and Cytolog report.	Duration of procedure: patient preparation, planning, guidance and Cytolog report.	6 month	No