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

NCT ID: NCT06944041

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-16

Study Completion Date

2025-02-20

Brief Summary

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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

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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.

Conditions

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Limb Volume Measuring Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Twenty limbs from ten healthy volunteers

STO3 sensor (Structure Inc., Boulder, CO)

Intervention Type OTHER

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.

Interventions

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STO3 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pre-existing diseased limbs
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Dr. Seshadri Raju

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The RANE Center for Venous and Lymphatic Diseases

Jackson, Mississippi, United States

Site Status

Countries

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United States

References

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Marsocci A, Santandrea S, Lanfranchi E, Donati D, Tedeschi R. Beyond water: 3D laser scanning offers a cutting-edge alternative for upper limb volume assessment. Phlebology. 2025 Jul;40(6):400-408. doi: 10.1177/02683555241310358. Epub 2024 Dec 19.

Reference Type BACKGROUND
PMID: 39701043 (View on PubMed)

Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg. 2000 Jun;31(6):1307-12. doi: 10.1067/mva.2000.107094.

Reference Type BACKGROUND
PMID: 10842165 (View on PubMed)

Raju S, Owen S Jr, Neglen P. Reversal of abnormal lymphoscintigraphy after placement of venous stents for correction of associated venous obstruction. J Vasc Surg. 2001 Nov;34(5):779-84. doi: 10.1067/mva.2001.119396.

Reference Type BACKGROUND
PMID: 11700475 (View on PubMed)

Katz ML, Comerota AJ, Kerr RP, Caputo GC. Variability of venous-hemodynamics with daily activity. J Vasc Surg. 1994 Feb;19(2):361-5. doi: 10.1016/s0741-5214(94)70111-3.

Reference Type BACKGROUND
PMID: 8114195 (View on PubMed)

Other Identifiers

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2024-008-St. Dom

Identifier Type: -

Identifier Source: org_study_id

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