An interventional study of Upper Limb Measurement Device in Upper Limb Volume Measurement, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Other
Among 100 studies in Breast Neoplasms by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — 62 open to participants now, 70 under way, 18 of them phase 3. Breast Neoplasms · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Among the 100 studies in Breast Neoplasms by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, this one is the 26th largest by enrollment of the 71 interventional ones, is one of 14 that started in 2025, is one of 20 with no phase, and was the 98th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 220 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →62 of the 100 studies in Breast Neoplasms by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University are open now, in 1 country. Each count lists the studies.
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →100 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 14 started in 2025.
Median enrollment 170 across the 71 interventional studies, 220 across the 29 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
12 of the studies in Breast Neoplasms by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07095023Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNeoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer | 2026-12-30 |
| NCT05862610Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe Study of Trilaciclib Combined With Chemotherapy On The Neoadjuvant Therapy of TNBC | 2026-12-30 |
| NCT07504367Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityLarge Language Models Assist in Tumor MDT | 2026-12-31 |
| NCT06024187Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityCold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial | 2026-12-31 |
| NCT06121557Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer | 2026-12-31 |
Among the 100 studies in Breast Neoplasms by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
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.
Time frame: Day 1
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.
Time frame: 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.
Time frame: Through study completion, approximately 6 months
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Jun 2025 to primary completion in Sep 2025, 3 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 3 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University →