Data Collection in Patients Undergoing CT-Guided Needle Interventions for NeedleWays System Development

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to collect CT images of patients undergoing CT Guided Needle Intervention Procedures which will be used for the development of the NeedleWaysTM System.

Detailed Description
-----------------
The study will collect anonymized data in support of further development of the NeedleWays System. The collected data will be: Anonymized CT scans with Patient Reference Frame (PRF) placed upon the scanned area, outside of the sterile field. Screen captures of the NeedleWays Procedure console display as the intervention needle is placed on the patients body, outside of the sterile field.

Official Title
-----------------
A Prospective Data Collection, Single-Center, Open Label Study in Patients Undergoing CT-Guided Needle Interventions for the Development of the NeedleWays System

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Device: NeedleWays™ System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Male or female subjects, 18 years of age or older at the time of enrollment. Subjects meeting all medical conditions for percutaneous CT-guided needle intervention. INR <1.4 Written informed consent to participate in the study. Ability to comply with the requirements of the study procedures. Exclusion Criteria Subjects diagnosed with one or more of the following according to medical records: Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting,Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia Subjects treated with Ticlopidine or similar antithrombotic medication. Subjects who cannot tolerate mild sedation Subjects with the following laboratory values, unless otherwise approved by hematologist: Platelet count <60,000/ml APTT >39 sec or PT >15 sec Pregnancy or lactation Subject is unable to comply with requirements of the procedure, i.e. holding breath. Subject participation in an investigational trial within 30 days of enrollment Subjects who are uncooperative or cannot follow instructions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeedleWays™ System<br>A total of 50 consecutive subjects scheduled for clinically indicated CT guided needle intervention procedure will be invited to enroll in the study. | Device: NeedleWays™ System<br>* A total of 50 consecutive subjects scheduled for clinically indicated CT guided needle intervention procedure will be invited to enroll in the study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collect CT images of patients undergoing CT | The primary objective of this study is to collect CT images of patients undergoing CT Guided Needle Intervention Procedures which will be used for the development of the NeedleWaysTM System. | procedure duration |