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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04258319
Enrollment
90
Registered
2020-02-06
Start date
2020-07-06
Completion date
2030-06-01
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

Brief summary

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_TESTUltrasound 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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

The unaffected arm will be used to serve as control for the affected extremity.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Viscoelasticity parameters with lymphedema as obtained using the SAVE methodBaselineDefined as the difference in viscoelastic parameters between the arm affected with lymphedema and the unaffected extremity (affected minus unaffected) using the sub-hertz analysis of viscoelasticity method

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAntonio Forte, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026