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

Mayo Clinic

Status: Invitation-only

Conditions: Lymphedema

Treatments: Diagnostic Test: Ultrasound Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04258319

18-005276

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Affected (Lymphedema)

Experimental group

Description:

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

Treatment:

Diagnostic Test: Ultrasound Procedure

Unaffected (Control)

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Ultrasound Procedure