NCT04821440

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-16
• Primary completion: 2021-09-23
• Completion: 2021-09-23
• First posted: 2021-03-29
• Last updated: 2025-02-04

Locations

2 sites across 1 country: France