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A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema

NCT05507346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2025-12-12

No results posted yet for this study

Summary

To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)

Conditions

  • Lymphedema
  • Lymphedema of Leg
  • Chronic Venous Insufficiency
  • Venous Insufficiency
  • Lymphedema, Lower Limb

Interventions

DEVICE

Cross over Device (PCD or Dayspring - alternate to first group)

Cross over after three month of use and a month of washout period

Sponsors & Collaborators

  • Koya Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2024-01-09
Completion
2024-01-09
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05507346 on ClinicalTrials.gov