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Enrolling by invitation NCT04258319

Sub-Hertz Analysis of Viscoelasticity of Limbs in Patients With Lymphedema

No phase Interventional Lymphedema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound Procedure.
Who it may be relevant to
Registry conditions: Lymphedema. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Researchers are trying to validate the use of ultrasound sub-hertz analysis of viscoelastisty (SAVE) method to monitor tissue-fluid dynamics and stage disease severity in patients diagnosed with lymphedema.

Interventions

  • Diagnostic test Ultrasound Procedure
    Ultrasound technique that uses a compression device integrated with ultrasound imaging to perform in vivo ramp-and-hold uniaxial creep-like test on upper extremity lymphedema (UEL) in vivo.

Primary outcome measures

  • Viscoelasticity parameters with lymphedema as obtained using the SAVE method [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Adult (18+ years of age)
  • Ability to provide written consent
  • Has been diagnosed with Lymphedema

Exclusion criteria

  • Under the age of 18 years old
  • Inability to provide written consent
  • Previous lymphovenous bypass or lymph node transfer surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 2 centers
  • Mayo Clinic — Jacksonville
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT04258319 · 18-005276

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗