NCT02329665

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 1, 2015

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

December 20, 2014

Last Update Submit

December 31, 2014

Conditions

Tumors

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

NeedleWays™ System

EXPERIMENTAL

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

Interventions

NeedleWays™ SystemDEVICE

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

NeedleWays™ System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2014

First Posted

January 1, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2016

Study Completion

May 1, 2016

Last Updated

January 1, 2015

Record last verified: 2014-12