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WithdrawnNCT03629964Updated May 8, 2020

Study to Develop Head Stabilizer for Use During Brain Radiation Therapy

An interventional study of Wiersma Head Stabilizer and AlignRT system in Brain Diseases and Brain Cancer, sponsored by University of Chicago. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-08.

Sponsored by University of Chicago · Not applicable, Interventional, and Device feasibility

Why this study was withdrawn
PI left site.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Brain Diseases
  • Brain Cancer
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In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 515 are open to participants now.

Browse Brain Neoplasms studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Adults undergoing whole brain radiation cancer treatment at the University of Chicago Medicine.

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Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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 · Device: AlignRT system

Interventions

  • DeviceWiersma Head Stabilizer

    Experimental device attached to treatment table.

  • DeviceAlignRT 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.

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What researchers measure

Primary outcomes

  1. Access feasibility of the use of an experimental head stabilizer device

    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

    Time frame: During radiation treatment (5-10 days)

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Study locations

1 site
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03629964
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Aug 14, 2018
Start date
Jul 16, 2018
Primary completion
Oct 1, 2019
Completion
Oct 1, 2019
Last update
May 8, 2020

Study contacts

Rodney Wiersma, PhD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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