Study to Develop Head Stabilizer for Use During Brain Radiation Therapy

NCT03629964 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-05-08

No results posted yet for this study

Summary

The purpose of this study is to begin to develop a device to stabilize the head during stereotactic radiosurgery (SRS). SRS is a therapy for brain disorders and cancers that uses a precise dose of radiation to treat a disease, and is different from whole brain radiation. This study aims to stabilize patient head motions during radiation therapy through the use of a special experimental head holder. The investigators would like to first see how the experimental device works in whole brain radiation.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Rodney Wiersma, PhD · University of Chicago

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2019-10-01
Completion
2019-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03629964 on ClinicalTrials.gov