Study to Develop Head Stabilizer for Use During Brain Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT03629964|
Recruitment Status : Withdrawn (PI left site.)
First Posted : August 14, 2018
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Brain Diseases Brain Cancer||Device: Wiersma Head Stabilizer Device: AlignRT system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Real-Time Head Position Stabilization of Patients Undergoing Radiation Therapy|
|Actual Study Start Date :||July 16, 2018|
|Actual Primary Completion Date :||October 1, 2019|
|Actual Study Completion Date :||October 1, 2019|
Experimental: Head stabilizer group
Patients will be receiving standard brain radiation. The experimental head holder device (called the Wiersma Head Stabilizer) will be attached to treatment table and will make small movements to adjust the position of the head in response to movement by the patient. In addition, the AlignRT system (an FDA approved medical device that automatically turns off the radiation beam if the patient's head moves beyond a set distance) will be used to track real-time motions of the head. This system is used with radiation therapy as standard of care.
Device: Wiersma Head Stabilizer
Experimental device attached to treatment table.
Device: AlignRT system
The AlignRT system (an FDA approved medical device that automatically turns off the radiation beam if the head moves beyond a set distance) will be used to track real-time motions of the head. This system is used with radiation therapy as standard of care.
- Access feasibility of the use of an experimental head stabilizer device [ Time Frame: During radiation treatment (5-10 days) ]Feasibility will be defined as to whether or not the 6D target is ≤ 0.5mm and ≤ 0.5deg for greater than 95% of treatment time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629964
|United States, Illinois|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Rodney Wiersma, PhD||University of Chicago|