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

Phase 4

Completed

• Conditions: Cancer
• Interventions: Other: ActiSight Needle Guidance System

• Registration Number: NCT01040884
• Lead Sponsor: ActiViews Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2009-12-29
• Study First Submitted QC: 2009-12-29
• Study First Posted: 2009-12-30
• Study Start: 2010-06
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ActiSight Needle Guidance System	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.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of needle punctures through the skin	During procedure
Number of CT scans needed	During procedure

Trial Locations

Locations (1)

ActiViews Ltd; 🇮🇱 Haifa, Israel