Back to resultsA Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema (TIBER)
Primary Purpose
Lymphedema, Lymphedema Lower Extremity, Chronic Venous Insufficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dayspring Active Wearable Compression System
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema
Eligibility Criteria
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
Sites / Locations
- PT works
- Ginger-K Lymphedema & Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with Lower Extremity Lymphedema and phlebolymphedema
Arm Description
Lower Extremity Lymphedema and phlebolymphedema
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Safety/AEs
As assessed by reported adverse events
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04897035
Brief Title
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
Acronym
TIBER
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koya Medical, Inc.
4. Oversight
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
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Lymphedema Lower Extremity, Chronic Venous Insufficiency, Secondary Lymphedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with Lower Extremity Lymphedema and phlebolymphedema
Arm Type
Experimental
Arm Description
Lower Extremity Lymphedema and phlebolymphedema
Intervention Type
Device
Intervention Name(s)
Dayspring Active Wearable Compression System
Intervention Description
Dayspring Active Wearable Compression System
Primary Outcome Measure Information:
Title
LYMQOL (LYMphedema Quality of Life)
Description
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.
Time Frame
3 months
Title
Limb Volume Maintenance or Improvement
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Safety/AEs
Description
As assessed by reported adverse events
Time Frame
3 months
Title
Therapy adherence tracking
Description
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.
Time Frame
3 months
Title
Patient survey
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
PT works
City
Los Altos
State/Province
California
ZIP/Postal Code
94024
Country
United States
Facility Name
Ginger-K Lymphedema & Cancer Center
City
Morgan Hill
State/Province
California
ZIP/Postal Code
95037
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
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