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NCT04258319 Clinical Trial

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

Lymphedema Clinical Trial

Official title:
Sub-Hertz Analysis of Viscoelasticity of Limbs in Patients With Lymphedema

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04258319
Other study ID # 18-005276
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date July 6, 2020
Est. completion date June 2024

Study information
Verified date July 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 90
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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.

Locations
Country Name City State
United States Mayo Clinic Jacksonville Florida
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Suspended NCT05366699 - LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy N/A
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