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

Tumors Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02329665
• Other study ID #: NW-CL-001P-IL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 20, 2014
• Last updated: December 31, 2014
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: December 2014
• Source: NeedleWays
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tumors

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NeedleWays

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No