Electromagnetic Tracking of Devices During Biopsy Procedures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01403727
First received: July 22, 2011
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

The purpose of the trial is to evaluate the differences between PercuNav assisted and unassisted biopsy in the areas of CT radiation dose, procedure time and biopsy accuracy.

This prospective, randomized, controlled trial will compare the use of electromagnetic tracking and image guidance (CT) during biopsy procedures verses the typical CT image guided procedure alone.


Condition
Liver Tumors

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Electromagnetic Tracking of Devices During Biopsy Procedures

Resource links provided by NLM:


Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Radiation Dose [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    The primary objective of this study is to assess and quantify any differences between assisted and unassisted CT guided biopsy procedures of the liver with respect to radiation dose.


Secondary Outcome Measures:
  • Total procedure time [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    Total procedure time is determined by the timespan of the moment the patient is accepted into the room (start) and the time when the procedure is complete (finish - when physician exits room).

  • Accuracy of needle targeting [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    Distance from defined target on PercuNav and angle of entry


Enrollment: 50
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Unassisted Biopsy - CONTROL GROUP
Routine biopsy needle placement and Physician blinded to needle location
Assisted Biopsy - STUDY GROUP
The physician will be shown the PercuNav screen and will correct the desired approach path.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing a liver biopsy procedure

Criteria

Inclusion Criteria:

  1. Has had a pre-operative CT scan performed and will be undergoing a biopsy procedure of the liver;
  2. Is over the age of 18;
  3. Has the ability to understand and the willingness to sign a written informed consent form, and complies with the protocol;
  4. Has the ability to follow procedural instructions, including, but not limited to, holding their breath and remaining reasonably motionless during the procedure.

Exclusion Criteria:

  1. Was precluded from a biopsy procedure based on standard exclusions;
  2. Has an adhesive allergy (due to the application of active fiducials with adhesive backing);
  3. Has a pacemaker or automatic implantable cardiac defibrillator;
  4. Has a gross body weight above 180lbs for women and 260lbs for men;
  5. Is pregnant

A patient may be excluded after enrollment if any of the following criteria are met:

1. The patient's health and/or safety become jeopardized for any reason making it unsafe to continue; 2. Technical errors and/or difficulties; 3. Any reasonable rationale put forth by the physician or investigator 4. Lost to follow up - In-evaluable data

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  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403727

Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Philips Healthcare
Investigators
Principal Investigator: Edward Kim, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01403727     History of Changes
Other Study ID Numbers: 2010_MtSinai_BiopTrial_V2
Study First Received: July 22, 2011
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Philips Healthcare:
Biopsy of liver tumors

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 16, 2014