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Measuring Volume Using a 3D Scanner and iPad to Grade the Swelling of Legs

Limb Volumetry Using iPad Based 3D Scanner for Assessment of Edema

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06944041
Enrollment
10
Registered
2025-04-25
Start date
2024-04-16
Completion date
2025-02-20
Last updated
2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limb Volume, Measuring Edema

Keywords

Leg swelling, 3-D Volumetry, phlebolymphedema, CEAP Clinical Class 3, Limb plethysmography, lymphedema

Brief summary

We used a new and easy-to-measure iPad 3D scanner to measure swelling in lower limbs because current technology is not easily available or affordable. We want to see how reliable the measurements are and what might affect how consistent they are.

Detailed description

Twenty limbs from ten healthy volunteers were scanned using an iPad-based Structure Sensor and software. Initial scans followed standard manufacturer instructions, but high variance rendered data unsuitable for clinical use. To improve accuracy, a standardized scanning protocol was developed, incorporating anatomical calibration, scanning distance standardization, and scanning time control. A 254-mm calf segment was defined using a 3D marker placed on the medial malleolus to ensure consistent volume measurement. The scanning distance was fixed between 50-59 cm to reduce zoom parallax errors, and scans were conducted after 3 PM to minimize diurnal volume fluctuations. Multiple technicians performed repeat scans on the same limb to assess intra-observer and inter-observer scan reliability.

Interventions

OTHERSTO3 sensor (Structure Inc., Boulder, CO)

The advent of Apple iPad based 3D scanner opens a new avenue for measuring limb volume. The latest ambient light scanner model was utilized for the current study. 3D scanning technology has gained broad industrial use, including the manufacturing of high-precision tools. A commercially available software package was used for limb volumetry.

Sponsors

The RANE Center for Venous and Lymphatic Diseases at St. Dominic's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* The people in this study will be symptom free volunteers.

Exclusion criteria

* Pre-existing diseased limbs

Design outcomes

Primary

MeasureTime frameDescription
Limb VolumeDuring ProcedureThe scanning protocol and the required modifications of out of the box instructions for optimal clinical application are described; The 10 inch (254mm) long limb segment scanned must be anatomically constant. We chose the medial malleolus as the lower border of the scan. The scannable limb volume is 254 mm long, measured up from the malleolus.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026