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LymphedemaNCT07921290

Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity

An observational study of Lymphedema and Upper Extremity Lymphedema, run by Karadeniz Technical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
How many people
64 participants
Where
No sites listed yet
Study dates
1 Feb 2027to 1 Jun 2028
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Healthy adult volunteers and clinical patients diagnosed with upper extremity lymphedema evaluated at the physical therapy and rehabilitation laboratories.

Who may be able to join

  • Healthy Volunteers:
  • Aged between 18 and 65 years
  • Voluntarily willing to participate and providing written informed consent
  • Absence of any known musculoskeletal or neuromuscular deformity, active edema, open wounds, or history of major upper extremity surgery
  • Lymphedema Patients:
  • Aged between 18 and 65 years
Show all 9Show fewer
  • Voluntarily willing to participate and providing written informed consent
  • Confirmed clinical diagnosis of upper extremity lymphedema
  • Absence of active skin lesions, open ulcerations, acute cellulitis, or lymphorrhea on the affected upper extremity

Who cannot join

  • Presence of open wounds, acute skin breakdown, lymphorrhea, active cutaneous infection (cellulitis, fungal infection), or severe dermatological lesions on the tested limb
  • Severe cognitive, systemic, or physical limitations preventing standard testing positioning (supine posture or holding the limb steady) or safe water immersion
  • Known severe skin allergy or dermatological hypersensitivity to silicone or adhesive fixation materials (for the healthy cohort undergoing the simulated edema protocol)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Burak Erturk, PT, PhD contact

+90 462 377 4250

burak.erturk@ktu.edu.tr

About this study

Official title: Comparison of Reliability, Time Cost, and Participant Comfort of Volumetric, Circumference Measurement, LiDAR, and 3D Modeling Methods in Upper Extremity Volume Measurement

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.

Read the detailed description

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:

  1. Water Displacement Volumetry: Conducted using a custom overflow tank and precision graduated cylinders as the reference standard. The hand volume is measured first and subtracted from the full-arm immersion volume. Strict decontamination protocols are applied between sessions.
  2. Circumference Measurement: Circumferential measures are taken at 4 cm intervals in a supine position and converted to limb volume using the truncated cone (Kuhnke/Frustum) formula. Measurements are obtained independently by both an experienced and an inexperienced evaluator.
  3. LiDAR-Based Scanning: Acquired using an iPad equipped with Structure Sensor 3 (Structure application). Standardized positioning is utilized with adhesive anatomical landmarks.
  4. Photogrammetric/Optical 3D Scanning: Acquired using the Creality Raptor X 3D scanner (Creality Scan software).

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.

Keywords
Limb Volume Measurement
Medical subject headings
Lymphedema, Breast Cancer Lymphedema, Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07921290
Study groupRoleWhat they receive
Healthy AdultsForty 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.
Patients with LymphedemaTwenty-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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assessed during the single cross-sectional experimental testing session (approximately 1 to 2 hours per participant).

Secondary outcomes (3)
  1. 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).

    Measured: 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)

  2. 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.

    Measured: Immediately after each measurement procedure and at the end of the visit (within 2 hours)

  3. 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.

    Measured: Immediately following baseline measurements during the single study visit (at approximately 1 hour post-baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start1 Feb 2027 (estimated)
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
64 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07921290
Sponsor's protocol ID
2026-232
Status last verified
Oct 2026
First submitted
30 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Huang X, Zheng W, Pearce R, Zhang Y. SSIPe: accurately estimating protein-protein binding affinity change upon mutations using evolutionary profiles in combination with an optimized physical energy function. Bioinformatics. 2020 Apr 15;36(8):2429-2437. doi: 10.1093/bioinformatics/btz926.

    PubMed 31830252
  • Glynn D, Campbell B, Marlow M, Patrick H. How to improve the quality of evidence when new treatments are funded conditional on collecting evidence of effectiveness and safety. J Health Serv Res Policy. 2016 Apr;21(2):71-2. doi: 10.1177/1355819615621584. Epub 2015 Dec 17. No abstract available.

    PubMed 26683884
  • Rodriguez-Mendez BG, Lopez-Callejas R, Mercado-Cabrera A, Pena-Eguiluz R, Valencia-Alvarado R, Betancourt-Angeles M, Berrones-Stringel G, Jaramillo-Martinez C. Harnessing Non-Thermal Plasma to Supercharge Recovery in Abdominal Surgeries: A Pilot Study. J Clin Med. 2024 Jan 11;13(2):408. doi: 10.3390/jcm13020408.

    PubMed 38256546
  • Murray A, Allen V. Angioplasty pressure-volume measurement. Med Biol Eng Comput. 1995 Sep;33(5):747-8. doi: 10.1007/BF02510800.

    PubMed 8523924
  • Lubinski J, Gorski B, Huzarski T, Byrski T, Gronwald J, Serrano-Fernandez P, Domagala W, Chosia M, Ucinski M, Grzybowska E, Lange D, Maka B, Mackiewicz A, Karczewska A, Breborowicz J, Lamperska K, Stawicka M, Gozdecka-Grodecka S, Bebenek M, Sorokin D, Wojnar A, Haus O, Sir J, Mierzwa T, Niepsuj S, Gugala K, Gozdz S, Sygut J, Kozak-Klonowska B, Musiatowicz B, Posmyk M, Kordek R, Morawiec M, Zambrano O, Wasko B, Fudali L, Skret J, Surdyka D, Urbanski K, Mitus J, Rys J, Szwiec M, Rozmiarek A, Dziuba I, Wandzel P, Wisniowski R, Szczylik C, Kozak A, Kozlowski W, Narod SA. BRCA1-positive breast cancers in young women from Poland. Breast Cancer Res Treat. 2006 Sep;99(1):71-6. doi: 10.1007/s10549-006-9182-3. Epub 2006 Mar 16.

    PubMed 16541315
  • Li J, Liu S, Fu J, Yin J, Zhao J, Zhong C, Cao G. Co-Occurrence of Colistin and Meropenem Resistance Determinants in a Stenotrophomonas Strain Isolated from Sewage Water. Microb Drug Resist. 2019 Apr;25(3):317-325. doi: 10.1089/mdr.2018.0418. Epub 2019 Mar 13.

    PubMed 30864883

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphedema and Upper Extremity Lymphedema, run by Karadeniz Technical University.

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 9 inclusion and 3 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Burak Erturk, PT, PhD (+90 462 377 4250, burak.erturk@ktu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Upper Extremity Limb Volume (time frame: Assessed during the single cross-sectional experimental testing session (approximately 1 to 2 hours per participant).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07921290, which also lists 6 linked publications.

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 6 Nov 2026.

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