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Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment

NCT07613931 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-05-29

No results posted yet for this study

Summary

The goal of this pilot study is to learn if a revised method of compression improves lymphatic function compared to the current method of compression. The main questions:

• Does the revised method of compression improve lymph movement and lymphatic propulsion?

Conditions

  • Lower Extremity Lymphedema

Interventions

DEVICE

Advanced pneumatic compression device (APCD)

Single APCD treatment session at visit 1

DEVICE

Advanced pneumatic compression device (APCD) with revised compression programming

APCD with revised compression programming will be single treatment session at visit 2

DRUG

Indocyanine Green (IC-Green)

Indocyanine Green dye will be used to assess primary endpoint

Sponsors & Collaborators

  • Tactile Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07613931 on ClinicalTrials.gov