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) studied | none |
| Date of first enrollment | 18/12/2025 |
| Target sample size | 10 |
| Countries of recruitment | |
| Study type | Interventional |
| 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 Outcome | 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 Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | <= 80age old |
| Gender | Both |
| Include criteria | 1. Adults aged 18 to 80 years old 2. Individuals who have provided consent for this study by signing the consent form themselves |
| Exclude 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 |
Related Information
| Primary Sponsor | Nakamura Katsumasa |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Katsumasa Nakamura |
| Address | Handayama 1-20-1, Chuo-ku, Hamamatsu, Shizuoka Shizuoka Japan 431-3192 |
| Telephone | +81-53-435-2242 |
| 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 |
| nakam@hama-med.ac.jp | |
| Affiliation | Hamamatsu University School of Medicine |