Safety And Accuracy Study Of The Actisight™ Needle Guidance System In Patients Undergoing CT-Guided Procedures

Cancer Clinical Trial

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 Aspiration, Biopsy and RF Ablations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040884
• Other study ID #: ASNG-LFNA-101-IL-H
• Status: Completed
• Phase: Phase 4
• First received: December 29, 2009
• Last updated: July 10, 2012
• Start date: June 2010
• Est. completion date: January 2012

Study information

• Verified date: July 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 preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients undergoing CT-guided percutaneous aspiration and RF Ablations The procedure will be performed by a trained physician. Subjects will be screened for inclusion in the study. Following signing of informed consent, screening procedures will be performed including demographic and medical history, vital signs, anthropometrics), chest radiography, if applicable and CT scanning, blood samples for coagulation indices (PT, APTT), if applicable, and pregnancy test in women of child-bearing potential.

Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation 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 chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. ** Note ** If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.

Description:

Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation 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 chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. ** Note ** If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• 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 aspiration/biopsy with safe path to lesion

• INR <1.4

• Written informed consent to participate in the study

• Ability to comply with the requirements of the study procedures

Exclusion Criteria:

• Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting

• Use of Aspirin or similar antithrombotic medication

• Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia

• Subjects who cannot tolerate mild sedation

• Subjects with the following laboratory values, unless approved by hematologist:

• Platelet count < 60,000/mL

• APTT > 39 sec or PT > 15 sec, INR > 1.4

• 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

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• 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
Israel	ActiViews Ltd	Haifa

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 (tip of the needle location) within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan		During procedure	No
Secondary	Number of needle punctures through the skin		During procedure	No
Secondary	Number of CT scans needed		During procedure	No