Electromagnetic Tracking of Devices During Biopsy Procedures

NCT01403727 | Completed

• 1 other identifier: 2010_MtSinai_BiopTrial_V2
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Tumors

Keywords

Biopsy of liver tumors

Outcome Measures

Primary Outcomes (1)

• Radiation Dose

  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.

  24 hrs

Secondary Outcomes (2)

• Total procedure time

  24 hrs

• Accuracy of needle targeting

  24 hrs

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a liver biopsy procedure

You may qualify if:

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

You may not qualify if:

• Has an adhesive allergy (due to the application of active fiducials with adhesive backing);
• Has a pacemaker or automatic implantable cardiac defibrillator;
• Has a gross body weight above 180lbs for women and 260lbs for men;
• Is pregnant
• A patient may be excluded after enrollment if any of the following criteria are met:
• \. 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

Sponsors & Collaborators

• Philips Healthcare: lead

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Edward Kim, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: July 27, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

US (1)