---
title: Sub-Hertz Analysis of Viscoelasticity of Limbs in Patients With Lymphedema
nct_id: NCT04258319
overall_status: ENROLLING_BY_INVITATION
phase: NA
sponsor: Mayo Clinic
study_type: INTERVENTIONAL
primary_condition: Lymphedema
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04258319.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04258319"
ct_last_update_post_date: 2025-08-14
last_seen_at: "2026-05-12T07:16:43.113Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Sub-Hertz Analysis of Viscoelasticity of Limbs in Patients With Lymphedema

**NCT ID:** [NCT04258319](https://clinicaltrials.gov/study/NCT04258319)

## Key Facts

- **Status:** ENROLLING_BY_INVITATION
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** Mayo Clinic
- **Conditions:** Lymphedema
- **Start Date:** 2020-07-06
- **Completion Date:** 2028-06
- **CT.gov Last Update:** 2025-08-14

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Affected (Lymphedema)** (EXPERIMENTAL) — Subjects affected lymphedema extremity will have elastic and viscoelastic parameters collected by ultrasound procedure
- **Unaffected (Control)** (ACTIVE_COMPARATOR) — Subjects unaffected extremity will have elastic and viscoelastic parameters collected by ultrasound procedure

## Interventions

- **Ultrasound Procedure** (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.

## Primary Outcomes

- **Viscoelasticity parameters with lymphedema as obtained using the SAVE method** _(time frame: Baseline)_ — 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

## Locations (2)

- Mayo Clinic, Jacksonville, Florida, United States
- Mayo Clinic, Rochester, Minnesota, United States

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mayo clinic|jacksonville|florida|united states` — added _(2026-05-12)_
- `locations.mayo clinic|rochester|minnesota|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04258319.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04258319*  
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