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

Primary Purpose

Lymphedema

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound Procedure
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic
  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Affected (Lymphedema)

Unaffected (Control)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 4, 2020
Last Updated
July 19, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04258319
Brief Title
Sub-Hertz Analysis of Viscoelasticity of Limbs in Patients With Lymphedema
Official Title
Sub-Hertz Analysis of Viscoelasticity of Limbs in Patients With Lymphedema
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The unaffected arm will be used to serve as control for the affected extremity.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Affected (Lymphedema)
Arm Type
Experimental
Arm Description
Subjects affected lymphedema extremity will have elastic and viscoelastic parameters collected by ultrasound procedure
Arm Title
Unaffected (Control)
Arm Type
Active Comparator
Arm Description
Subjects unaffected extremity will have elastic and viscoelastic parameters collected by ultrasound procedure
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound Procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Viscoelasticity parameters with lymphedema as obtained using the SAVE method
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Forte, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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