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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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

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Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

NeedleWays™ System

Intervention Type DEVICE

A total of 50 consecutive subjects scheduled for clinically indicated CT guided needle intervention procedure will be invited to enroll in the study.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No