A 3D Tablet Sensor Approach to the Measurement of a Lymphedema (LO3D)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Lymphedema

Treatments: Device: Three dimension volumetry; Device: Water displacement volumetry

Study type: Interventional

Funder types: Other

Identifiers

NCT04821440

29BRC20.0049

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Lower Limb Lymphedema

Active Comparator group

Description:

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

Treatment:

Device: Water displacement volumetry

Device: Three dimension volumetry

Upper Limb Lymphedema

Active Comparator group

Description:

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

Treatment:

Device: Water displacement volumetry

Device: Three dimension volumetry