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Compression Device

Cross over Device (PCD or Dayspring - alternate to first group) for Leg Lymphedema (TEAYS Trial)

N/A
Waitlist Available
Research Sponsored by Koya Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

TEAYS Trial Summary

This trial is to compare the effectiveness of the Koya device to a standard compression device for people with lymphedema.

Eligible Conditions
  • Leg Lymphedema
  • Lymphedema
  • Chronic Venous Insufficiency
  • Venous Insufficiency
  • Lower Limb Lymphedema

TEAYS Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
LYMQOL
Limb volume reduction or maintenance
Therapy adherence tracking
Secondary outcome measures
Patient survey on preference
Safety/AEs

TEAYS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Dayspring, Non-Pneumatic Active Compression Device (NPCD)Experimental Treatment1 Intervention
The Dayspring, an Non-Pneumatic Active Compression Device (NPCD) Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure compression garment that is segmental and programmable and applies controlled sequential pressure from the distal to proximal-end of the limb in a cyclic manner.
Group II: Advanced Pneumatic Compression Device (APCD)Active Control1 Intervention
A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cross over Device (PCD or Dayspring - alternate to first group)
2022
N/A
~130

Find a Location

Who is running the clinical trial?

Koya Medical, Inc.Lead Sponsor
5 Previous Clinical Trials
262 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial have an age restriction, and if so what is the threshold?

"This clinical trial is searching for participants aged 18 to 100 years. Additionally, there are 4 separate trials available that target patients younger than 18 and another one hundred studies intended for those 65 and older."

Answered by AI

Is there an open enrollment period for this clinical trial?

"Confirming, clinicaltrials.gov displays that this medical trial is presently engaging participants. It was initially posted on September 6th 2022 and has been recently changed on November 9th 2022. 50 test subjects are required between a single location."

Answered by AI

How many participants are currently included in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this trial is still underway and recruiting participants since its launch on September 6th 2022. 50 individuals are required at one medical centre for the trial; it was last updated November 9th of the same year."

Answered by AI

Who meets the criteria to take part in this clinical experiment?

"Eligible candidates for this trial must be between 18 and 100 years of age, with lower extremity difficulties. There are 50 open slots in the study."

Answered by AI

Who else is applying?

What state do they live in?
California
Washington
Alabama
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Stanley G Rockson
How many prior treatments have patients received?
1
2

Why did patients apply to this trial?

I don't get satisfactory response in symptoms when using my sequential pneumatic pump.
PatientReceived no prior treatments
i have right lower leg lymphedema and use the flexitouch pump nightly, looking for something that works better.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How many visits does the study require?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
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
2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05507346.
~47 spots leftby Apr 2025
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