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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT04258319
Status
Enrolling By Invitation

Conditions

  • Lymphedema

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound Procedure — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Jul 6, 2020
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Affected (Lymphedema)
    Subjects affected lymphedema extremity will have elastic and viscoelastic parameters collected by ultrasound procedure
  • Active Comparator: Unaffected (Control)
    Subjects unaffected extremity will have elastic and viscoelastic parameters collected by ultrasound procedure

Primary Outcome Measure

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

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicJacksonvilleFlorida32224-
Mayo ClinicRochesterMinnesota55905-

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