Development of a Mask-Free Head and Neck Immobilization System

A Study on the Fixation Accuracy of a Maskless Head and Neck Immobilization System for Surface-Guided Radiation Therapy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042250142

Enrollment

Registered

2025-12-12

Start date

2025-12-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

none

Interventions

Using the body surface-guided radiation therapy device, measure the ROI position with Identify, then perform head fixation measurements using the open face mask and the mask-free head and neck fixatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 to 80 years old 2. Individuals who have provided consent for this study by signing the consent form themselves

Exclusion criteria

Exclusion criteria: 1. Individuals with claustrophobia 2. Individuals with mandibular disorders 3. Other individuals deemed unsuitable for participation in the study by the principal investigator or sub-investigator

Design outcomes

Primary

Measure	Time frame
Time-dependent changes in the angles of the roll, pitch, and yaw rotation of the 3D vector along the X, Y, and Z axes of the region of interest (ROI) obtained from Identify during fixation with an open face mask and head-neck fixation system.	—

Secondary

Measure	Time frame
1) Survey results regarding feelings of pressure or discomfort 2) Angles of rotation (roll, pitch, yaw) of the 3D vector along the X, Y, and Z axes of the ROI caused by forced movements 3) Presence or absence of adverse events	—

Contacts

Public ContactKatsumasa Nakamura

Hamamatsu University School of Medicine

nakam@hama-med.ac.jp+81-53-435-2242

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026