Upper Limb Volume MeasurementNCT07898410
Clinical Trial of an Upper Limb Measurement Device
A study testing Upper Limb Measurement Device in people with Upper Limb Volume Measurement, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Volume Measurement
- What is being tested?
- Upper Limb Measurement Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2025to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants aged 18 to 70 years.
- Participants will primarily be patients who have undergone breast cancer surgery; healthy volunteers will account for no more than 20% of the total study population.
- Participants whose upper limb circumference, measured manually at the wrist crease and elbow crease using a non-elastic measuring tape, meets the distribution requirements within the device's linear measurement range of 11 to 56 cm.
- Participants who are willing and able to provide written informed consent.
Who cannot join
- Participants with infectious skin lesions or skin diseases, such as psoriasis or eczema.
- Participants with open wounds, abrasions, or active bleeding of the upper limb.
- Participants who are unable to maintain a fixed and stable position during the measurement procedure.
- Participants with an upper limb length, measured from the fingertip to the axilla using a non-elastic measuring tape, of less than 50 cm or greater than 80 cm.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
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.
- Conditions
- Upper Limb Volume Measurement
- Being tested
- Upper Limb Measurement Device
- Keywords
- Upper Limb Volume Measurement, Upper Limb Measurement Device, Upper Limb Lymphedema, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Limb Measurement DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Upper Limb Volume Measurement | Experimental | Participants underwent upper limb volume measurements using both the investigational upper limb measurement device and the reference water displacement method. Each upper limb was measured three times using each method, and the mean of the three measurements was used for comparison. The order of the two measurement methods was randomized. The measurements were performed independently by separate study personnel to minimize potential measurement bias. Receives: Device: Upper Limb Measurement Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bland-Altman Limits of Agreement for Upper Limb Volume Measurements Between the Investigational Device and the Water Displacement Method
Each upper limb will be measured three times using both the investigational device and the water displacement method. The mean measurements will be compared using Bland-Altman analysis to assess agreement between the two methods.
Measured: Day 1
Secondary outcomes (2)
Number of Participants Experiencing Device-Related Adverse Events
The number and percentage of participants experiencing adverse events related to the investigational upper limb measurement device will be recorded during the measurement procedure on Day 1.
Measured: Day 1
Number of Investigational Device Malfunctions or Deficiencies
The total number of malfunctions or deficiencies involving the investigational upper limb measurement device will be recorded throughout the clinical study, including failures in data acquisition, quality control failures, and other device-related technical problems. The frequency and types of device malfunctions or deficiencies will be summarized.
Measured: Through study completion, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start4 Jun 2025
- Primary completion12 Sep 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Volume MeasurementStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898410
- Sponsor's protocol ID
- SYSQX-2025-015-01
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the study protocol did not include a prospective plan for sharing de-identified participant-level data, and the informed consent process did not specifically address data sharing with external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of an Upper Limb Measurement Device
- ClinicalTrials.gov ID
- NCT07898410
- Acronym / sponsor ID
- SYSQX-2025-015-01
- Conditions
- Upper Limb Volume Measurement
- Keywords
- Upper Limb Volume Measurement, Upper Limb Measurement Device, Upper Limb Lymphedema, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper Limb Volume Measurement | Experimental | Device: Upper Limb Measurement DeviceParticipants underwent upper limb volume measurements using both the investigational upper limb measurement device and the reference water displacement method. Each upper limb was measured three times using each method, and the mean of the three measurements was used for comparison. The order of the two measurement methods was randomized. The measurements were performed independently by separate study personnel to minimize potential measurement bias. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged 18 to 70 years.
- Participants will primarily be patients who have undergone breast cancer surgery; healthy volunteers will account for no more than 20% of the total study population.
- Participants whose upper limb circumference, measured manually at the wrist crease and elbow crease using a non-elastic measuring tape, meets the distribution requirements within the device's linear measurement range of 11 to 56 cm.
- Participants who are willing and able to provide written informed consent.
Key exclusion criteria (4 listed)
- Participants with infectious skin lesions or skin diseases, such as psoriasis or eczema.
- Participants with open wounds, abrasions, or active bleeding of the upper limb.
- Participants who are unable to maintain a fixed and stable position during the measurement procedure.
- Participants with an upper limb length, measured from the fingertip to the axilla using a non-elastic measuring tape, of less than 50 cm or greater than 80 cm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper Limb Measurement DeviceThe 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. | Device | Upper Limb Volume Measurement |
Primary outcome
Bland-Altman Limits of Agreement for Upper Limb Volume Measurements Between the Investigational Device and the Water Displacement Method
Time frame: Day 1
Each upper limb will be measured three times using both the investigational device and the water displacement method. The mean measurements will be compared using Bland-Altman analysis to assess agreement between the two methods.
2 secondary outcomes
Number of Participants Experiencing Device-Related Adverse Events
Time frame: Day 1
Number of Investigational Device Malfunctions or Deficiencies
Time frame: Through study completion, approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the study protocol did not include a prospective plan for sharing de-identified participant-level data, and the informed consent process did not specifically address data sharing with external researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Limb Measurement Device in people with Upper Limb Volume Measurement, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bland-Altman Limits of Agreement for Upper Limb Volume Measurements Between the Investigational Device and the Water Displacement Method (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.