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

Lymphedema Clinical Trial

— LO3D  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04821440
• Other study ID #: 29BRC20.0049
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2021
• Est. completion date: December 16, 2023

Study information

• Verified date: October 2023
• Source: University Hospital, Brest
• Contact: Simon GESTIN
• Phone: 02 98 34 75 45
• Email: simon.gestin[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 16, 2023
• Est. primary completion date: December 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU de Brest	Brest
France	CH Pont l'Abbé	Pont-l'Abbé

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reproducibility of measurements made with a 3D sensor for lymphedema volumetry	Intra-class correlation coefficient (ICC)	One hour