A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema (TIBER)

A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

Study Overview

• Status: Completed
• Conditions: Lymphedema; Secondary Lymphedema; Chronic Venous Insufficiency; Lymphedema Lower Extremity
• Intervention / Treatment: Device: Dayspring Active Wearable Compression System

Detailed Description

A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Altos, California, United States, 94024
      • PT works
    • Morgan Hill, California, United States, 95037
      • Ginger-K Lymphedema & Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females ≥ 18 years of age
• Willing to sign the informed consent and deemed capable of following the study protocol
• Subjects must have a diagnosis of primary or secondary unilateral lower extremity edema
• At the time of initial evaluation, individuals must be at least 3 months post surgery, chemotherapy and/or radiation treatment for cancer if applicable

Exclusion Criteria:

• Individuals with a history or presence of an acute systemic disorder or condition that could place the patient at increased risk from sequential compression therapy
• Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
• Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
• Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
• Diagnosis of lipedema
• Diagnosis of active or recurrent cancer (< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
• Diagnosis of Acute infection (in the last four weeks)
• Diagnosis of acute thrombophlebitis (in last 6 months)
• Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
• Diagnosis of pulmonary edema
• Diagnosis of congestive heart failure (uncontrolled)
• Diagnosis of chronic kidney disease with acute renal failure
• Diagnosis of epilepsy
• Patients with poorly controlled asthma
• Any condition where increased venous and lymphatic return is undesirable
• Women who are pregnant, planning a pregnancy or nursing at study entry
• Participation in any clinical trial of an investigational substance or device during the past 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Subjects with Lower Extremity Lymphedema and phlebolymphedema; Lower Extremity Lymphedema and phlebolymphedema	Device: Dayspring Active Wearable Compression System; Dayspring Active Wearable Compression System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LYMQOL (LYMphedema Quality of Life)	The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, was also administered at baseline and at month 3. Overall QoL is scored on a single item by the patient on a scale of 1-10. The outcome measure is assessed as a difference or change from baseline LYMQOL at day zero and month 3.	3 months
Limb Volume Maintenance or Improvement	Limb volume measurement is performed by using a calibrated tape measure to measure circumference from the ankle and at 4cm increments to the waist region. Measurements are taken for both lower extremities. Volume is calculated based on cylindrical segment analysis.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety/AEs	As assessed by reported adverse events	3 months
Therapy adherence tracking	Therapy adherence tracked via the mobile app that records usage per day. Outcome measure will be evaluated based on recommended use of 45 minutes per day over the duration of 3 months.	3 months
Patient survey	A visual analog scale (VAS) 1-5 and study survey were administered at the end of the study to measure patient satisfaction. The six-item questionnaire was used to document the time of day the device was used, if daily activities were supported during use, function, and symptoms. The VAS was administered to previous users of pneumatic compression devices to assess preference and likelihood to recommend to others with lymphedema.	3 months

Collaborators and Investigators

• Sponsor: Koya Medical, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2021
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): July 1, 2022

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (ACTUAL): May 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Lymphatic Diseases; Lymphedema; Venous Insufficiency
• Other Study ID Numbers: KCT 006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No