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Comparing Navigation With Xperguide vs. Electromagnetic Tracking vs. Conventional Methods During Percutaneous Image Guided Procedures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01287013
First Posted: February 1, 2011
Last Update Posted: October 20, 2017
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.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
  Purpose

Background:

- Procedures that use medical tools in or near a possible abnormality in the body often use computed tomography (CT) scans to locate the abnormality and guide the path that a needle will take to collect a sample of tissue. Xperguide and electromagnetic (EM) tracking are two new procedures being studied to help guide the needle. Xperguide is software that uses CT images to help the doctor choose the needle path. EM tracking uses special medical tools with miniature coils that act like a GPS device to show the location of the needle in the body. Xperguide and EM tracking have been used in humans and have good results, but they have not been compared with each other and regular CT to determine whether they are better than the standard approach.

Objectives:

- To compare the results of Xperguide, electromagnetic tracking, and regular computed tomography during a guided percutaneous procedure.

Eligibility:

- Individuals at least 18 years of age who are required to have a CT-guided percutaneous procedure.

Design:

  • Participants will be screened with a physical examination and medical history, and the results of any previous imaging studies will be examined before study enrollment.
  • After a pilot phase, the study will involve two phases to compare the results of the different procedures. The first phase will involve comparing Xperguide to CT, and the second will involve comparing Xperguide to EM tracking.
  • Phase 1 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have regular CT. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method.
  • Phase 2 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have EM tracking. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method.
  • Standard post-procedure followup care will be given after the study procedure is completed.

Condition Intervention Phase
Infection Cancer Neoplasm Empyema Granuloma Device: Xperguide CT Device: Computed Tomography Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Randomized Trial Comparing Navigation With Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Comparing Xperguide to conventional imaging (superiority design) [ Time Frame: 2.5 years ]
  • Comparing Xperguide to EM tracking (equivalence design) [ Time Frame: 2.5 years ]

Secondary Outcome Measures:
  • Compare total time of procedure [ Time Frame: 2.5 years ]
  • Compare time to target -To compare the number of CBCT or number of verifications CT during a procedure [ Time Frame: 2.5 years ]
  • Compare the number of CBCT or number of verifications CT during a procedure [ Time Frame: 2.5 years ]

Enrollment: 87
Study Start Date: January 2011
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
Will have the procedure performed with Xperguide
Device: Xperguide CT
Imaging
Group B
Will have the procedure performed with regular CT
Device: Computed Tomography
Imaging

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. they are over 18 years of age
    2. they are scheduled for image guided procedure
    3. the lesion is not superficial (deeper than 3 cm)

EXCLUSION CRITERIA:

  1. patients with an altered mental status that precludes understanding or consenting for the procedure
  2. patients unable to hold reasonably still on a procedure table for the length of the procedure
  3. patient unable to hold their breath if the procedure will be performed with conscious sedation and without general anesthesia
  4. patient with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287013


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
Principal Investigator: Bradford Wood, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01287013     History of Changes
Other Study ID Numbers: 110082
11-CC-0082
First Submitted: January 25, 2011
First Posted: February 1, 2011
Last Update Posted: October 20, 2017
Last Verified: April 2015

Keywords provided by National Institutes of Health Clinical Center (CC):
Image Guided Procedures
Xperguide CT
Electromagnetic Tracking
Navigation
Image Guided Procedure
Cancer
Granuloma

Additional relevant MeSH terms:
Granuloma
Empyema
Lymphoproliferative Disorders
Lymphatic Diseases
Pathologic Processes
Suppuration
Infection
Inflammation