Clinical trial NCT04659564: Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study
Official title: Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Related Lymphedema
Lymphedema of Upper Arm
Lymphedema
Quality of Life
Lead sponsor: Koya Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

1. Improvement in QoL in subject with upper-extremity edema after 28 days as measured by the LYMQOL disease-specific validated assessment tool.
2. Arm volume maintenance or improvement as measured prior to and after 28 days of device use.
3. Safety as assessed by reported adverse events
4. Patient satisfaction as measured by visual analog scale (VAS) and survey at the end of the study; and
5. Adherence to therapy as measured with a smart phone app.


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

Primary outcomes:
measure: LYMQOL (LYMphedema Quality of Life)
timeFrame: 28 days
measure: Arm Volume Maintenance or Improvement
timeFrame: 28 days
measure: Safety/AEs
timeFrame: 28 days
measure: Therapy adherence tracking
timeFrame: 28 days
Secondary outcomes:
measure: Patient survey
timeFrame: 28 days
Other outcomes:
Locations:
city: Los Altos
country: United States
facility: PT works
state: California
city: Morgan Hill
country: United States
facility: Ginger-K Lymphedema & Cancer Center
state: California
Study officials:
affiliation: Medical Advisor
name: Stanley G Rockson, MD
role: PRINCIPAL_INVESTIGATOR
References: