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

NCT04258319 | Enrolling By Invitation

• 1 other identifier: 18-005276
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

• Viscoelasticity parameters with lymphedema as obtained using the SAVE method

  Defined 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

  Baseline

Study Arms (2)

Affected (Lymphedema)

EXPERIMENTAL

Subjects affected lymphedema extremity will have elastic and viscoelastic parameters collected by ultrasound procedure

Diagnostic Test: Ultrasound Procedure

Unaffected (Control)

ACTIVE COMPARATOR

Subjects unaffected extremity will have elastic and viscoelastic parameters collected by ultrasound procedure

Diagnostic Test: Ultrasound Procedure

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.

Affected (Lymphedema); Unaffected (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lymphedema

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Antonio Forte, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: July 6, 2020
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)