A 3D Tablet Sensor Approach to the Measurement of a Lymphedema

Not Applicable

Completed

• Conditions: Lymphedema
• Interventions: Device: Water displacement volumetry; Device: Three dimension volumetry

• Registration Number: NCT04821440
• Lead Sponsor: University Hospital, Brest

Brief Summary

Up to now, the diagnosis of lymphedema remains hard and delayed. It suffers from many limitations such as lack of coordination and formation of the health-care network. The diversity of used tools is another obstacle because all provided solutions on the market are either costless with poor accuracy, or highly expensive but with excellent accuracy. Therefore, we decided to evaluate an affordable and open-source 3D iPad sensor sharing the same technology used in Kinect sensors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-29
• Study Start: 2021-06-16
• Primary Completion: 2021-09-23
• Study Completion: 2021-09-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Unilateral lymphedema

Exclusion Criteria

• Minor patient,
• Bilateral lymphedema,
• Trophic disorders: Acute or recent skin infection (<1 month after the end of antibiotic therapy), unhealed wounds.
• Predictable difficulties in carrying out the measurements due to the patient's physical limitations (maintenance of orthostatic or sitting position <5 minutes)
• Single or bilateral edema with a different etiology than lymphedema.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lower Limb Lymphedema	Water displacement volumetry	Patients suffering from unilateral lower-limb lymphedema will receive volume measurements of their limb three times, once with the water displacement method, twice with the 3D sensor method
Lower Limb Lymphedema	Three dimension volumetry	Patients suffering from unilateral lower-limb lymphedema will receive volume measurements of their limb three times, once with the water displacement method, twice with the 3D sensor method
Upper Limb Lymphedema	Water displacement volumetry	Patients suffering from unilateral upper-limb lymphedema will receive volume measurements of their limb three times, once with the water displacement method, twice with the 3D sensor method
Upper Limb Lymphedema	Three dimension volumetry	Patients suffering from unilateral upper-limb lymphedema will receive volume measurements of their limb three times, once with the water displacement method, twice with the 3D sensor method

Primary Outcome Measures

Name	Time	Method
Accuracy of a 3D sensor for lymphedema volumetry	One hour	Intra-class correlation coefficient (ICC) Mean bias and limits of agreement (LOA) derived from the Blant-Altman diagram Mean bias and limits of agreement (LOA) derived from the Blant-Altman diagram

Secondary Outcome Measures

Name	Time	Method
Reproducibility of measurements made with a 3D sensor for lymphedema volumetry	One hour	Intra-class correlation coefficient (ICC)

Trial Locations

Locations (2)

CHU de Brest; 🇫🇷 Brest, France

CH Pont l'Abbé; 🇫🇷 Pont-l'Abbé, France