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

NCT04821440 | Completed

• 1 other identifier: 29BRC20.0049
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Lymphedema

Keywords

3D sensor; Lower Extremity; Upper Extremity; Body Regions; Measurement; Monitoring; Water displacement; Volume

Outcome Measures

Primary Outcomes (1)

• Accuracy of a 3D sensor for lymphedema volumetry

  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

  One hour

Secondary Outcomes (1)

• Reproducibility of measurements made with a 3D sensor for lymphedema volumetry

  One hour

Study Arms (2)

Lower Limb Lymphedema

ACTIVE COMPARATOR

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

Device: Water displacement volumetry; Device: Three dimension volumetry

Upper Limb Lymphedema

ACTIVE COMPARATOR

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

Device: Water displacement volumetry; Device: Three dimension volumetry

Interventions

Water displacement volumetry DEVICE

The examination will take place in several stages and by two operators. Initially, the patient will strip the limb concerned (leg or arm). Once the member is in the water column of the volumeter, a delimitation of the submerged area of the member will be carried out using a marking (black dermographic marker). Indeed, the level of acquisition in 3D is determined relative to the height of the water line marked on the skin with a black felt, this felt is usually used for venous mapping and is well tolerated The first operator will carry out two measurements one after the other with a change of water previously stabilized at room temperature.

Lower Limb Lymphedema; Upper Limb Lymphedema

Three dimension volumetry DEVICE

The 3D volumetric acquisition is done with the sensor (CE marking) attached to the touch pad and does not require invasive or cutaneous contact with the patient (minimum acquisition distance of 40 cm). The operator triggers the acquisition via a button in an application installed on the tablet and physically turns around the patient to carry out the acquisition of the affected member. At the end of the acquisition, the operator presses a stop button and chooses whether or not to calculate the volume using another button depending on the quality of the acquisition.

Lower Limb Lymphedema; Upper Limb Lymphedema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Unilateral lymphedema

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHU de Brest

Brest, 29200, France

Location

CH Pont l'Abbé

Pont-l'Abbé, France

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: March 29, 2021
• Study Start: June 16, 2021
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: February 4, 2025

Record last verified: 2025-02

Locations

FR (2)