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Enrolling by invitationNCT04258319Updated Jul 10, 2026

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

An interventional study of Ultrasound Procedure in Lymphedema, sponsored by Mayo Clinic. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Lymphedema

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03

In context

Lymphedema

529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.

This study's planned enrollment of 90 is above the median of 50 across 369 interventional studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult (18+ years of age)
  • Ability to provide written consent
  • Has been diagnosed with Lymphedema

Exclusion criteria

Exclusion Criteria:

  • Under the age of 18 years old
  • Inability to provide written consent
  • Previous lymphovenous bypass or lymph node transfer surgery
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Affected (Lymphedema)

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

    Diagnostic Test: Ultrasound Procedure

  • Active comparator
    Unaffected (Control)

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

    Diagnostic Test: Ultrasound Procedure

Interventions

  • Diagnostic testUltrasound 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

07

Study locations

2 sites
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2020 (actual). Primary completion is estimated for Jun 2028, 95 months after the start.

Of 175 non-industry interventional studies with no phase under Lymphedema, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 68. This study's planned 95 months is above that.

Counting every sponsor, half of 197 studies reached it within 25 months; a quarter within 9 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2020
First posted
Feb 6, 2020
StartActual
Jul 6, 2020
Primary completionEst.
Jun 2028
CompletionEst.
Jun 2030
Last update
Jul 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04258319
Lead sponsor
Mayo Clinic
Responsible party
Antonio J. Forte (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Feb 6, 2020
Start date
Jul 6, 2020
Primary completion
Jun 2028 (estimated)
Completion
Jun 2030 (estimated)
Last update
Jul 10, 2026

Study contacts

Antonio Forte, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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