Back to resultsA Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of the Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema (NILE)
Primary Purpose
Lymphedema, Lymphedema of Upper Arm, Lymphedema, Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Crossover Device (PCD or Dayspring - alternate to first group)
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 upper extremity edema
Exclusion Criteria:
- Individuals with a history or presence of a systemic disorder or condition that could place the subject 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
- Subjects with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
- Subjects 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 renal failure
- Diagnosis of epilepsy
- Subjects 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 worksRecruiting
- Ginger-K Lymphedema & Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dayspring Active Wearable Compression Device
Advanced Pneumatic Compression Device
Arm Description
The Dayspring Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure full-arm 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.
A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device.
Outcomes
Primary Outcome Measures
Arm Volume Maintenance or Improvement
Limb volume measurement is 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 to be taken for both upper extremities. Volume is calculated based on cylindrical segment analysis. The outcome measure is assessed as a difference or change from baseline to month 1
LYMQOL (LYMphedema Quality of Life)
The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, is also administered at baseline and month 1. 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 1
Secondary Outcome Measures
Safety/AEs
As assessed by reported adverse events
Therapy adherence tracking
A table will be provided to patient to document days of use with the device to track adherence
Patient survey on preference
A study survey administered at the end of the study to measure patient preference between the two devices
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04908254
Brief Title
A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of the Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema
Acronym
NILE
Official Title
A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
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
To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD)
Detailed Description
A Multi-center Randomized Control Single Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema. To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Lymphedema of Upper Arm, Lymphedema, Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single Crossover
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dayspring Active Wearable Compression Device
Arm Type
Experimental
Arm Description
The Dayspring Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure full-arm 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.
Arm Title
Advanced Pneumatic Compression Device
Arm Type
Active Comparator
Arm Description
A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device.
Intervention Type
Device
Intervention Name(s)
Crossover Device (PCD or Dayspring - alternate to first group)
Intervention Description
Cross over arms after a month of use and a month of washout period
Primary Outcome Measure Information:
Title
Arm Volume Maintenance or Improvement
Description
Limb volume measurement is 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 to be taken for both upper extremities. Volume is calculated based on cylindrical segment analysis. The outcome measure is assessed as a difference or change from baseline to month 1
Time Frame
1 month
Title
LYMQOL (LYMphedema Quality of Life)
Description
The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, is also administered at baseline and month 1. 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 1
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Safety/AEs
Description
As assessed by reported adverse events
Time Frame
1 month
Title
Therapy adherence tracking
Description
A table will be provided to patient to document days of use with the device to track adherence
Time Frame
1 month
Title
Patient survey on preference
Description
A study survey administered at the end of the study to measure patient preference between the two devices
Time Frame
1 month
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 upper extremity edema
Exclusion Criteria:
Individuals with a history or presence of a systemic disorder or condition that could place the subject 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
Subjects with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
Subjects 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 renal failure
Diagnosis of epilepsy
Subjects 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stanley G Rockson, MD
Phone
4158510337
Email
info@koyamedical.com
Facility Information:
Facility Name
PT works
City
Los Altos
State/Province
California
ZIP/Postal Code
94024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Nguyen
Phone
415-851-0337
Email
info@koyamedical.com
Facility Name
Ginger-K Lymphedema & Cancer Center
City
Morgan Hill
State/Province
California
ZIP/Postal Code
95037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phyllis T Tubbs-Gingerich
Phone
415-851-0337
Email
info@koyamedical.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Multi-center Randomized Control Cross-over Study to Evaluate the Safety and Effectiveness of the Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema
We'll reach out to this number within 24 hrs