NCT02329665

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: NeedleWays · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-02-01
• Completion: 2016-05-01
• First posted: 2015-01-01
• Last updated: 2015-01-01