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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02329665
Recruitment Status : Unknown
Verified December 2014 by NeedleWays.
Recruitment status was:  Not yet recruiting
First Posted : January 1, 2015
Last Update Posted : January 1, 2015
Sponsor:
Information provided by (Responsible Party):
NeedleWays

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.

Condition or disease Intervention/treatment Phase
Tumors Device: NeedleWays™ System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : February 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. collect CT images of patients undergoing CT [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: NeedleWays
ClinicalTrials.gov Identifier: NCT02329665    
Other Study ID Numbers: NW-CL-001P-IL
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: January 1, 2015
Last Verified: December 2014