Back to resultsClinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study (DAYSPRING)
Primary Purpose
Breast Cancer Related Lymphedema, Lymphedema of Upper Arm, Lymphedema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
User of Dayspring device
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Related 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 or bilateral upper extremity edema
Exclusion Criteria:
- Individuals with a history or presence of a 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.)
- Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer
- Diagnosis of Acute infection (in the last two weeks)
- Diagnosis of acute thrombophlebitis (in last 2 months)
- Diagnosis of peripheral arterial disease (PAD): PAD is defined as an Ankle Brachial Index (ABI), of 0.7 or lower
- 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
- 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
Other
Arm Label
Breast-cancer related lymphedema (BCRL)
Arm Description
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 day 28. Overall QoL is scored on a single item by the patient on a scale of 1-10.
Arm Volume Maintenance or Improvement
Limb volume measurement was performed by using a calibrated tape measure to measure circumference from the wrist and the ulnar styloid process and at 4cm increments to the axilla. Measurements were taken for both upper extremities. If both extremities exhibited edema, a study arm was designated for treatment. Measurements were taken by the same investigator throughout the study. Volume was calculated based on cylindrical segment analysis.
Safety/AEs
As assessed by reported adverse events
Therapy adherence tracking
Therapy adherence tracked via the mobile app linked to the Dayspring™ device.
Secondary Outcome Measures
Patient survey
A visual analog scale (VAS) and study survey were administered at the end of the study to measure patient satisfaction (day 28). 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. All were measured on a scale from 1-5. 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
NCT04659564
Brief Title
Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study
Acronym
DAYSPRING
Official Title
Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
May 28, 2021 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
An open-label study to clinically assess a novel wearable advanced compression technology (Dayspring™) undertaken to determine if potential barriers to lymphedema self-care were effectively addressed. The Dayspring™ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential compression system. The following endpoints are examined:
Improvement in QoL in subject with upper-extremity edema after 28 days as measured by the LYMQOL disease-specific validated assessment tool.
Arm volume maintenance or improvement as measured prior to and after 28 days of device use.
Safety as assessed by reported adverse events
Patient satisfaction as measured by visual analog scale (VAS) and survey at the end of the study; and
Adherence to therapy as measured with a smart phone app.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Related Lymphedema, Lymphedema of Upper Arm, Lymphedema, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breast-cancer related lymphedema (BCRL)
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
User of Dayspring device
Intervention Description
The Dayspring™ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential 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 day 28. Overall QoL is scored on a single item by the patient on a scale of 1-10.
Time Frame
28 days
Title
Arm Volume Maintenance or Improvement
Description
Limb volume measurement was performed by using a calibrated tape measure to measure circumference from the wrist and the ulnar styloid process and at 4cm increments to the axilla. Measurements were taken for both upper extremities. If both extremities exhibited edema, a study arm was designated for treatment. Measurements were taken by the same investigator throughout the study. Volume was calculated based on cylindrical segment analysis.
Time Frame
28 days
Title
Safety/AEs
Description
As assessed by reported adverse events
Time Frame
28 days
Title
Therapy adherence tracking
Description
Therapy adherence tracked via the mobile app linked to the Dayspring™ device.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Patient survey
Description
A visual analog scale (VAS) and study survey were administered at the end of the study to measure patient satisfaction (day 28). 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. All were measured on a scale from 1-5. The VAS was administered to previous users of pneumatic compression devices to assess preference and likelihood to recommend to others with lymphedema.
Time Frame
28 days
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 or bilateral upper extremity edema
Exclusion Criteria:
Individuals with a history or presence of a 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.)
Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer
Diagnosis of Acute infection (in the last two weeks)
Diagnosis of acute thrombophlebitis (in last 2 months)
Diagnosis of peripheral arterial disease (PAD): PAD is defined as an Ankle Brachial Index (ABI), of 0.7 or lower
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley G Rockson, MD
Organizational Affiliation
Medical Advisor
Official's Role
Principal Investigator
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
Learn more about this trial
Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study
We'll reach out to this number within 24 hrs