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

Sponsor

University Hospital, Brest (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04821440

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphedema	Device: Water displacement volumetry Device: Three dimension volumetry	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

A 3D Tablet Sensor Approach to the Measurement of an Upper and Lower Limb Volume in the Monitoring of a Lymphedema

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lower Limb Lymphedema 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 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. Device: Three dimension volumetry 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.
Active Comparator: Upper Limb Lymphedema 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 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. Device: Three dimension volumetry 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.

Arm

Intervention/Treatment

Active Comparator: Lower Limb Lymphedema

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

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.

Device: Three dimension volumetry

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.

Active Comparator: Upper Limb Lymphedema

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.