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Diagnostic Test

Ultrasound Analysis for Lymphedema

N/A
Waitlist Available
Led By Antonio Forte, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult (18+ years of age)
Has been diagnosed with Lymphedema
Must not have
Under the age of 18 years old
Previous lymphovenous bypass or lymph node transfer surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a new ultrasound method can help doctors better understand and treat lymphedema.

Who is the study for?
This trial is for adults over 18 who have been diagnosed with lymphedema and can give written consent. It's not open to those under 18, anyone unable to consent, or patients who've had certain surgeries like lymphovenous bypass or lymph node transfer.
What is being tested?
The study is testing a new ultrasound technique called SAVE that measures how fluid moves in tissues and helps determine the severity of lymphedema. Researchers want to see if this method is effective for monitoring the condition.
What are the potential side effects?
Since the intervention involves an ultrasound procedure, side effects are minimal but may include temporary discomfort at the site of application or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
I have been diagnosed with Lymphedema.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
Select...
I have had surgery to improve lymph flow.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Viscoelasticity parameters with lymphedema as obtained using the SAVE method

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Affected (Lymphedema)Experimental Treatment1 Intervention
Subjects affected lymphedema extremity will have elastic and viscoelastic parameters collected by ultrasound procedure
Group II: Unaffected (Control)Active Control1 Intervention
Subjects unaffected extremity will have elastic and viscoelastic parameters collected by ultrasound procedure

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,871 Total Patients Enrolled
6 Trials studying Lymphedema
492 Patients Enrolled for Lymphedema
Antonio Forte, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

Sub-Hertz Analysis of Viscoelasticity (SAVE) Method (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT04258319 — N/A
Lymphedema Research Study Groups: Unaffected (Control), Affected (Lymphedema)
Lymphedema Clinical Trial 2023: Sub-Hertz Analysis of Viscoelasticity (SAVE) Method Highlights & Side Effects. Trial Name: NCT04258319 — N/A
Sub-Hertz Analysis of Viscoelasticity (SAVE) Method (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04258319 — N/A
Lymphedema Patient Testimony for trial: Trial Name: NCT04258319 — N/A
~22 spots leftby Jun 2026
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