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

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

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.

Study Overview

• Status: Unknown
• Conditions: Tumors
• Intervention / Treatment: Device: NeedleWays™ System

Detailed Description

The study will collect anonymized data in support of further development of the NeedleWays System.

The collected data will be:

1. Anonymized CT scans with Patient Reference Frame (PRF) placed upon the scanned area, outside of the sterile field.
2. Screen captures of the NeedleWays Procedure console display as the intervention needle is placed on the patients body, outside of the sterile field.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: NeedleWays

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: December 20, 2014
• First Submitted That Met QC Criteria: December 31, 2014
• First Posted (Estimate): January 1, 2015

Study Record Updates

• Last Update Posted (Estimate): January 1, 2015
• Last Update Submitted That Met QC Criteria: December 31, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: NW-CL-001P-IL