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JAPANESE
JRCT ID: jRCTs042250142

Registered date:12/12/2025

Development of a Mask-Free Head and Neck Immobilization System

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiednone
Date of first enrollment18/12/2025
Target sample size10
Countries of recruitment
Study typeInterventional
Intervention(s)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 fixation system.

Outcome(s)

Primary OutcomeTime-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 Outcome1) 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

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 80age old
GenderBoth
Include criteria1. Adults aged 18 to 80 years old 2. Individuals who have provided consent for this study by signing the consent form themselves
Exclude criteria1. 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

Related Information

Contact

Public contact
Name Katsumasa Nakamura
Address Handayama 1-20-1, Chuo-ku, Hamamatsu, Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2242
E-mail nakam@hama-med.ac.jp
Affiliation Hamamatsu University School of Medicine
Scientific contact
Name Katsumasa Nakamura
Address Handayama 1-20-1, Chuo-ku, Hamamatsu, Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2242
E-mail nakam@hama-med.ac.jp
Affiliation Hamamatsu University School of Medicine