Tumors
Conditions
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.
Interventions
DEVICENeedleWays™ System
A total of 50 consecutive subjects scheduled for clinically indicated CT guided needle intervention procedure will be invited to enroll in the study.
Sponsors
NeedleWays
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed