Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
NCT07921290, Not yet recruiting, Karadeniz Technical University
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity | ClinicalTrials.gov |
| NCT number | NCT07921290 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 64 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Karadeniz Technical University | ClinicalTrials.gov |
| Conditions | Lymphedema, Upper Extremity Lymphedema, Breast Cancer Related Lymphedema, Edema | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Upper Extremity Limb Volume | Assessed during the single cross-sectional experimental testing session (approximately 1 to 2 hours per participant). | 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. | ClinicalTrials.gov |
| Secondary | Procedural Time Cost (Process Duration) | 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) | 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). | ClinicalTrials.gov |
| Secondary | Participant-Perceived Discomfort and Fatigue | Immediately after each measurement procedure and at the end of the visit (within 2 hours) | 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. | ClinicalTrials.gov |
| Secondary | Sensitivity to Localized Small Volume Changes (Simulated Edema Absolute Error) | Immediately following baseline measurements during the single study visit (at approximately 1 hour post-baseline) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)