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Validation of a New Method of Limb Volumetry

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ClinicalTrials.gov Identifier: NCT01574911
Recruitment Status : Unknown
Verified April 2012 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : April 10, 2012
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date April 6, 2012
First Posted Date April 10, 2012
Last Update Posted Date April 20, 2012
Study Start Date April 2012
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2012)
Difference between limb volume measured [ Time Frame: 36 months ]
Difference between limb volume measured during the same session by water displacement and by 3D laser scanner
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of a New Method of Limb Volumetry
Official Title Development and Validation of a Limb Volumetry Technique Applicable in Daily Clinical Practice Using Self Positioning 3D Laser Scanning:Reproductibility and Comparison to the Reference Method
Brief Summary

Volumetry is essential for the diagnosis and follow-up of patients with limb edema. The objective of this project is the validation of real-time reconstruction and calculation of limb volume using a 3D laser scanner.

Water - displacement volumetry (water-filled boot) is the reference method with known accuracy and reproducibility, but is not commonly used in clinical practice because it is cumbersome, difficult, and time-consuming. The most commonly used method remains segmental limb perimetry with a tape measure, followed by volume calculation using the truncated cones formula, thus excluding de facts extremities (hands and feet) which can neither be likened to cones nor easily measured.

Quantification limb volume and volume changes is essential for the diagnosis and follow-up of patients with chronic venous insufficiency or lymphedema, two very common pathological conditions. It is mandatory for the evaluation of therapeutic approaches.

The present study will use an innovative technology of volume acquisition by freehand laser scanning with a hand-held camera with Quantification limb volume and volume changes is essential for the diagnosis and follow-up of patients with chronic venous insufficiency or lymphedema, two very common pathological conditions. It is mandatory for the evaluation of therapeutic approaches.

The present study will use an innovative technology of volume acquisition by freehand laser scanning with a hand-held camera with real-time 3D reconstruction.

Its advantages are non-contact, accurate and detailed quantification of edema, including extremities, allowing to assess the magnitude and topography of physiological, pathological, or treatment - induced volume changes. This approach will ultimately provide data that will used for designing personalized limb compression ortheses.

Detailed Description

In each subject and patient, limb volume will be measured once by water - displacement (WD) and twice by 3D laser scanning (3D), by 2 independent operators, in random order. In a subgroup of patients, measurements will be repeated in the morning and evening, twice a year (during winter and during summer) to estimate the nycthemeral and seasonal effects.

Measurements will be performed in healthy subjects and in patients with chronic venous insufficiency or lymphedema.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Validation study an innovative non-invasive diagnostic technique. Biomedical research conducted with the help of Montpellier University Hospital Clinical Investigation Center (CIC) for the recruitment of healthy controls, and vascular Medicine clinics for the recruitment of patients with chronic venous insufficiency or lymphedema
Sampling Method Probability Sample
Study Population Recruitment of healthy controls and vascular Medicine clinics for the recruitment of patients with chronic venous insufficiency or lymphedema
Condition
  • Edema
  • Chronic Venous Insufficiency
  • Lymphedema
Intervention Not Provided
Study Groups/Cohorts
  • healthy adults
    The objective of this project is the validation of real time reconstruction and calculation of limb volume using a 3 D laser scanner In each subject limb volume will be measured once by water - displacement and twice by 3D laser scanning
  • Adults Chronic venous insufficiency
    The objective of this project is the validation of real time reconstruction and calculation of limb volume using a 3 D laser scanner In each subject limb volume will be measured once by water - displacement and twice by 3D laser scanning
  • patients primary lymphedema
    The objective of this project is the validation of real time reconstruction and calculation of limb volume using a 3 D laser scanner In each subject limb volume will be measured once by water - displacement and twice by 3D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 9, 2012)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Either healthy adult or - Adult and chronic venous insufficiency C1s, C3, or C5 (CEAP classification) or - Primary lymphedema (between 10-90 years old)

Exclusion Criteria:

  • No consent form
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01574911
Other Study ID Numbers UF8834
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Montpellier
Study Sponsor University Hospital, Montpellier
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Montpellier
Verification Date April 2012