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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01671163
Other study ID # IRB201600243
Secondary ID 326-2012
Status Terminated
Phase
First received
Last updated
Start date July 2012
Est. completion date August 12, 2019

Study information

Verified date August 2019
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 18
Est. completion date August 12, 2019
Est. primary completion date August 12, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Florida/Shands Gainesville Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system. 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.
approximately one week
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