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

NeedleWays

Status: Unknown

Conditions: Tumors

Treatments: Device: NeedleWays™ System

Study type: Interventional

Funder types: Other

Identifiers

NCT02329665

NW-CL-001P-IL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

NeedleWays™ System

Experimental group

Description:

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

Treatment:

Device: NeedleWays™ System