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

NCT ID: NCT04258319

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphedema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

OTHER

Blinding Strategy

NONE

Study Groups

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Affected (Lymphedema)

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

Group Type EXPERIMENTAL

Ultrasound Procedure

Intervention Type 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.

Unaffected (Control)

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

Group Type ACTIVE_COMPARATOR

Ultrasound Procedure

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Antonio J. Forte

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Forte, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Jacksonville, Florida, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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18-005276

Identifier Type: -

Identifier Source: org_study_id

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