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Clinical Trial of an Upper Limb Measurement Device
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Summary
This clinical study evaluates an upper limb measurement device designed to measure upper limb volume. The study will compare measurements obtained using the upper limb measurement device with those obtained using the water displacement method. The study will assess the effectiveness, accuracy, consistency, and measurement time of the device, as well as its safety and usability. Approximately 220 participants will be enrolled, including primarily patients who have undergone breast cancer treatment and a small proportion of healthy participants. Each participant will undergo upper limb volume measurements using both methods, with the measurement order randomized.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2025-06-04
Completion Date
2025-11-26
Last Updated
2026-10-27
Healthy Volunteers
Yes
Conditions
Interventions
Upper Limb Measurement Device
The investigational upper limb measurement device (model ULMS-RKRM201) is a non-invasive automated device designed to measure upper limb circumference and volume. During measurement, the participant places the hand and upper arm in designated positions within the acquisition unit. Cameras capture images of the upper limb, and software algorithms automatically identify the wrist and elbow and calculate upper limb circumference and volume. The device generates an automated measurement report, and a single measurement of one upper limb is completed within 60 seconds.
Locations (1)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China