Back to resultsA 3D Tablet Sensor Approach to the Measurement of a Lymphedema (LO3D)
Primary Purpose
Lymphedema
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Water displacement volumetry
Three dimension volumetry
Sponsored by
About this trial
This is an interventional health services research trial for Lymphedema focused on measuring 3D sensor, Lower Extremity, Upper Extremity, Body Regions, Measurement, Monitoring, Water displacement, Volume
Eligibility Criteria
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.
Sites / Locations
- CHU de BrestRecruiting
- CH Pont l'AbbéRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lower Limb Lymphedema
Upper Limb Lymphedema
Arm 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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Reproducibility of measurements made with a 3D sensor for lymphedema volumetry
Intra-class correlation coefficient (ICC)
Full Information
NCT ID
NCT04821440
First Posted
May 26, 2020
Last Updated
October 11, 2023
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT04821440
Brief Title
A 3D Tablet Sensor Approach to the Measurement of a Lymphedema
Acronym
LO3D
Official Title
A 3D Tablet Sensor Approach to the Measurement of an Upper and Lower Limb Volume in the Monitoring of a Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
December 16, 2023 (Anticipated)
Study Completion Date
December 16, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
3D sensor, Lower Extremity, Upper Extremity, Body Regions, Measurement, Monitoring, Water displacement, Volume
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lower Limb Lymphedema
Arm Type
Active Comparator
Arm 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
Arm Title
Upper Limb Lymphedema
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Water displacement volumetry
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Three dimension volumetry
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accuracy of a 3D sensor for lymphedema volumetry
Description
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
Time Frame
One hour
Secondary Outcome Measure Information:
Title
Reproducibility of measurements made with a 3D sensor for lymphedema volumetry
Description
Intra-class correlation coefficient (ICC)
Time Frame
One hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon GESTIN
Phone
02 98 34 75 45
Email
simon.gestin@chu-brest.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Wit HAERTLE
Phone
06 82 50 86 14
Email
dr@haertle.fr
Facility Information:
Facility Name
CHU de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon GESTIN, PH
First Name & Middle Initial & Last Name & Degree
Simon GESTIN, PH
Facility Name
CH Pont l'Abbé
City
Pont-l'Abbé
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wit HAERTLE, PH
First Name & Middle Initial & Last Name & Degree
Wit HAERTLE, PH
12. IPD Sharing Statement
Learn more about this trial
A 3D Tablet Sensor Approach to the Measurement of a Lymphedema
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