An observational study in Lymphedema, Upper Extremity Lymphedema and Breast Cancer Related Lymphedema, sponsored by Karadeniz Technical University. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Karadeniz Technical University · Observational
This study aims to evaluate and compare the measurement reliability, total time cost (preparation, acquisition, post-processing), and participant comfort of conventional limb volume measurement methods (water displacement volumetry, tape-based circumference measurement) against modern digital techniques (LiDAR-based mobile scanning, stereophotogrammetric 3D optical scanning) in the upper extremity. The evaluation will be conducted on both healthy adults and patients diagnosed with upper extremity lymphedema. Additionally, the impact of assessor experience on digital data post-processing and the sensitivity of the methods to detect small localized volume increases using a simulated edema model (50 mL) will be investigated.
Upper extremity lymphedema is a chronic and progressive condition characterized by the accumulation of protein-rich interstitial fluid, leading to tissue fibrosis and structural volume increases. Precise, reliable, and practical limb volume measurement is vital for diagnosis, staging, and therapeutic monitoring. While water displacement volumetry remains the gold standard, it poses practical challenges including cross-contamination risks, prolonged setup, and inapplicability to patients with wounds or severe limitations. Circumference tape measurement with frustum modeling is widely used but suffers from high examiner dependency and geometric approximation errors. Emerging non-contact technologies, such as mobile Light Detection and Ranging (LiDAR) sensors and optical 3D surface scanning, offer rapid, hygienic, and objective alternatives. However, gaps remain regarding their sensitivity to subclinical volume variations, the influence of post-processing operator experience, procedural time costs, and participant burden.
This methodological, comparative, cross-sectional pilot study evaluates upper extremity volume assessment methods across two cohorts: healthy adults (n = 40) and individuals clinically diagnosed with upper extremity lymphedema (n = 24). Measurements are conducted on the dominant upper extremity in healthy participants and on the affected upper extremity in patients with lymphedema, demarcated from the ulnar styloid process to 2-3 cm distal to the axilla.
All participants undergo the following sequentially:
To address operator dependency in digital workflows, raw 3D point-cloud processing, mesh trimming, and volumetric integration are performed under a blinded protocol by both an experienced operator and an inexperienced operator.
In the healthy adult cohort, a simulated localized edema protocol is additionally conducted to determine method sensitivity to small volume fluctuations. A non-absorbent medical silicone pad (calibrated to exactly 50 mL via prior water volumetry) is affixed to the participant's forearm, after which circumference, LiDAR, and 3D optical scanning procedures are repeated.
Comprehensive time-motion analyses are recorded with a digital stopwatch across three distinct phases for each modality: equipment preparation, data acquisition, and post-processing computation. Participant-reported outcomes, including physical discomfort and fatigue, are documented using a Visual Analog Scale (VAS, 0-100 mm) immediately after each test and ranked comparatively at session conclusion.
124 studies on the registry are indexed under Breast Cancer Lymphedema; 40 are open to participants now.
This study's planned enrollment of 64 is below the median of 80 across 25 observational studies indexed under Breast Cancer Lymphedema.
Browse Breast Cancer Lymphedema studies →Karadeniz Technical University is the lead sponsor of 153 studies on the registry; 22 are open to participants now.
Compared within Breast Cancer Lymphedema, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lymphedema. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Healthy adult volunteers and clinical patients diagnosed with upper extremity lymphedema evaluated at the physical therapy and rehabilitation laboratories.
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.
Healthy Volunteers:
Lymphedema Patients:
Exclusion Criteria (Both Groups):
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Forty healthy adult volunteers aged 18 to 65 years with no known deformity, edema, open wound, or prior surgical history in the upper extremity. Participants undergo baseline upper extremity volume assessments on their dominant arm using water displacement volumetry, tape-based circumference measurement (performed independently by experienced and inexperienced evaluators), LiDAR-based scanning (Structure Sensor 3), and stereophotogrammetric 3D optical scanning (Creality Raptor X). Additionally, to determine method sensitivity to small volume fluctuations, participants undergo a simulated edema protocol wherein a calibrated 50 mL non-absorbent medical silicone pad is affixed to the forearm, followed by repeat circumference, LiDAR, and 3D optical scans.
Twenty-four adult individuals aged 18 to 65 years clinically diagnosed with upper extremity lymphedema, without active skin lesions, open wounds, or lymphorrhea on the affected limb. Participants undergo upper extremity volume measurements on their affected arm using water displacement volumetry, tape-based circumference measurement (performed independently by experienced and inexperienced evaluators), LiDAR-based scanning (Structure Sensor 3), and stereophotogrammetric 3D optical scanning (Creality Raptor X). The simulated edema protocol is not applied to this cohort.
Upper Extremity Limb Volume
Total upper extremity limb volume (measured in milliliters, mL) evaluated across four measurement modalities: water displacement volumetry (gold standard reference), circumference tape measurement (calculated using the truncated cone / Frustum formula), LiDAR-based scanning (Structure Sensor 3), and stereophotogrammetric 3D optical scanning (Creality Raptor X). Measurement agreement and reliability will be determined using the Intraclass Correlation Coefficient (ICC Model 3,1) and Bland-Altman limits of agreement. Digital 3D model post-processing and tape measurements will be evaluated comparatively between experienced and inexperienced assessors.
Time frame: Assessed during the single cross-sectional experimental testing session (approximately 1 to 2 hours per participant).
Procedural Time Cost (Process Duration)
Total time cost (measured in minutes and seconds using a digital stopwatch) required for each modality, tracked across three distinct phases: preparation time (equipment setup, sanitation, and participant positioning), data acquisition time (actual measurement/scanning), and analysis/post-processing time (mathematical formula calculation or digital point-cloud cropping and mesh volume computation).
Time frame: Throughout the 4-hour experimental protocol window (from 1 hour prior to participant arrival, during the 2-hour assessment session, through 1 hour following participant departure)
Participant-Perceived Discomfort and Fatigue
Participant-reported physical discomfort and fatigue assessed immediately following each measurement modality using a Visual Analog Scale (VAS, 0 to 10 cm, where 0 represents 'no discomfort/fatigue' and 10 represents 'extreme discomfort/fatigue'). Overall method preference and willingness to repeat the procedure will be ranked at the conclusion of all tests.
Time frame: Immediately after each measurement procedure and at the end of the visit (within 2 hours)
Sensitivity to Localized Small Volume Changes (Simulated Edema Absolute Error)
Absolute measurement error (calculated in milliliters, mL) in detecting an artificial, localized 50 mL volume increase. In the healthy adult cohort, a calibrated, non-absorbent medical silicone pad (50 mL verified via water displacement) is affixed to the forearm. The error is determined as the absolute difference between the volume change detected by circumference tape, LiDAR, and 3D optical scanning and the true 50 mL volume of the pad.
Time frame: Immediately following baseline measurements during the single study visit (at approximately 1 hour post-baseline)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared publicly because this investigation constitutes the foundational baseline phase of a multi-stage longitudinal research project. The acquired normative volumetric, photographic, and point-cloud datasets will be actively utilized as prospective control and benchmark data in subsequent interrelated clinical and technological validation phases.
Start is estimated for Feb 2027; primary completion for Feb 2028, 12 months later.
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 not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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