Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system.

Outcome Description:

The outcome measure for this study is to determine: The successful delivery, to the targeted tissue,of the fiducials through the fiducial delivery system, The accuracy of the fiducial delivery into the targeted tissue and to see if the fiducials can be visualized via Endoscopic Ultrasound (EUS), Fluoroscopy and/or CT scan. The success and accuracy of the delivery will be evaluated by Endoscopic Ultrasound, fluoroscopy and/or CT scan to determine if the fiducials are in the targeted tissue. The subject's Oncologist will inform the endoscopist of the targeted tissue that is to receive the fiducials.

Outcome Time Frame:

approximately one week

Safety Issue:

No

Principal Investigator

Peter V Draganov, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida

Authority:

United States: Institutional Review Board

Study ID:

endoscopic fiducial placement

NCT ID:

NCT01671163

Start Date:

July 2012

Completion Date:

August 2015

Related Keywords:

• Cancer
• Cancer
• Radiation therapy
• Fiducial markers