LymphedemaTIBERNCT04897035
Study to Evaluate the Safety and Effectiveness of Dayspring for Lower Extremity Lymphedema
A study testing Dayspring Active Wearable Compression System in people with Lymphedema and Lymphedema Lower Extremity, run by Koya Medical, Inc. at 2 sites in United States.
Trial summary
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema, Lymphedema Lower Extremity, Chronic Venous Insufficiency
- What is being tested?
- Dayspring Active Wearable Compression System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PT works
Los Altos, California, 94024
Ginger-K Lymphedema & Cancer Center
Morgan Hill, California, 95037
About this study
Official title: A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
- Conditions
- Lymphedema, Lymphedema Lower Extremity, Chronic Venous Insufficiency, Secondary Lymphedema
- Being tested
- Dayspring Active Wearable Compression System
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dayspring Active Wearable Compression SystemDevice
Dayspring Active Wearable Compression System
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Lower Extremity Lymphedema and phlebolymphedema | Experimental | Lower Extremity Lymphedema and phlebolymphedema Receives: Device: Dayspring Active Wearable Compression System |
What is being measured
The primary outcome is the main question the study is designed to answer.
LYMQOL (LYMphedema Quality of Life) ***All Relevant Time Points Used in the Calculation in the Time Frame (e.g., Baseline and 3 Months).***
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.
Higher value is better on the QoL outcome and is more favorable.
Measured: 3 months
Change in Edema Volume
Change in edema volume is measured as the difference between the edema volume at 3 months and edema volume at baseline. Edema volume is the difference in volume between the affected and unaffected limb. 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.
A greater change in edema volume between the two time points is better on reduction of limb volume/swelling.
Measured: 3 months
Secondary outcomes (2)
Safety/AEs
As assessed by reported adverse events
Measured: 3 months
Number of Patients Using the Device Every Day for at Least 45 Minutes
Outcome measure will be evaluated based on number of patients that have used the device for the recommended use of 45 minutes per day over the duration of 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Jun 2021
- Primary completion30 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koya Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897035
- Sponsor's protocol ID
- KCT 006
- Acronym
- TIBER
- Status last verified
- Jan 2026
- First submitted
- 12 May 2021
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
- ClinicalTrials.gov ID
- NCT04897035
- Acronym / sponsor ID
- TIBER / KCT 006
- Conditions
- Lymphedema, Lymphedema Lower Extremity, Chronic Venous Insufficiency, Secondary Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Koya Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Lower Extremity Lymphedema and phlebolymphedema | Experimental | Device: Dayspring Active Wearable Compression SystemLower Extremity Lymphedema and phlebolymphedema |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dayspring Active Wearable Compression SystemDayspring Active Wearable Compression System | Device | Subjects with Lower Extremity Lymphedema and phlebolymphedema |
Primary outcome
LYMQOL (LYMphedema Quality of Life) *All Relevant Time Points Used in the Calculation in the Time Frame (e.g., Baseline and 3 Months).*
Time frame: 3 months
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. Higher value is better on the QoL outcome and is more favorable.
Change in Edema Volume
Time frame: 3 months
Change in edema volume is measured as the difference between the edema volume at 3 months and edema volume at baseline. Edema volume is the difference in volume between the affected and unaffected limb. 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. A greater change in edema volume between the two time points is better on reduction of limb volume/swelling.
2 secondary outcomes
Safety/AEs
Time frame: 3 months
Number of Patients Using the Device Every Day for at Least 45 Minutes
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dayspring Active Wearable Compression System in people with Lymphedema and Lymphedema Lower Extremity, run by Koya Medical, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LYMQOL (LYMphedema Quality of Life) *All Relevant Time Points Used in the Calculation in the Time Frame (e.g., Baseline and 3 Months).* (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.