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

Not Applicable

• Conditions: Tumors
• Interventions: Device: NeedleWays™ System

• Registration Number: NCT02329665
• Lead Sponsor: NeedleWays

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:

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 Timeline

• Status Verified: 2014-12
• Study First Submitted: 2014-12-20
• Study First Submitted QC: 2014-12-31
• Last Update Submitted: 2014-12-31
• Study First Posted: 2015-01-01
• Last Update Posted: 2015-01-01
• Study Start: 2015-02
• Primary Completion: 2016-02
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeedleWays™ System	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.

Primary Outcome Measures

Name	Time	Method
collect CT images of patients undergoing CT	procedure duration	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.