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Endoscopic Ultrasound-Guided Fiducial Placement for Stereotactic Body Radiotherapy

This study is currently recruiting participants.
Verified September 2017 by University of Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT01671163
First Posted: August 23, 2012
Last Update Posted: September 15, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
August 1, 2012
August 23, 2012
September 15, 2017
July 2012
October 2017   (Final data collection date for primary outcome measure)
Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system. [ Time Frame: approximately one week ]

The outcome measure for this study is to determine:

  1. The successful delivery, to the targeted tissue,of the fiducials through the fiducial delivery system,
  2. The accuracy of the fiducial delivery into the targeted tissue and
  3. 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.

Same as current
Complete list of historical versions of study NCT01671163 on ClinicalTrials.gov Archive Site
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Endoscopic Ultrasound-Guided Fiducial Placement for Stereotactic Body Radiotherapy
EUS-Guided Fiducial Placement for Stereotactic Body Radiotherapy
The purpose of this research study is to evaluate placing the radiation therapy markers (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an Endoscopic Ultrasound (EUS). This is a procedure using a special endoscope that has an ultrasound on the end. The ultrasound will allow the doctor's to see where the radiation therapy markers (Fiducial) is to be placed as outlined by the Radiation Oncologist.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
All subjects who are currently scheduled to undergo fiducial placement at the University of Florida in Gainesville as medically indicated.
Cancer
Procedure: Endoscopic Ultrasound (EUS) for fiducial placement
Endoscopic Ultrasound (EUS) used for the placement of fiducial markers in tissue as outlined by the radiation oncologist
Subjects requiring fiducial placement
Endoscopic Ultrasound (EUS) for fiducial placement
Intervention: Procedure: Endoscopic Ultrasound (EUS) for fiducial placement
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
October 2017
October 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years or older,
  • Scheduled to undergo fiducial placement,
  • Subject must be able to give informed consent

Exclusion Criteria:

  • Any contraindication to performing endoscopy,
  • Participation in another research protocol that could interfere or influence the outcomes measures of the present study,
  • The subject is unable/unwilling to give informed consent
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Peter V Draganov, MD 352-273-9474 peter.draganov@medicine.ufl.edu
United States
 
 
NCT01671163
IRB201600243
326-2012 ( Other Identifier: University of Florida Institutional Review Board )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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University of Florida
University of Florida
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Principal Investigator: Peter V Draganov, MD University of Florida
Principal Investigator: Robert Zlotecki, MD University of Florida
University of Florida
September 2017