Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study

NCT04659564 | Completed FDA Device

• 1 other identifier: KCT001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

Breast Cancer Related Lymphedema; Lymphedema of Upper Arm; Lymphedema; Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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.

  28 days

• 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.

  28 days

• Safety/AEs

  As assessed by reported adverse events

  28 days

• Therapy adherence tracking

  Therapy adherence tracked via the mobile app linked to the Dayspring™ device.

  28 days

Secondary Outcomes (1)

• Patient survey

  28 days

Study Arms (1)

Breast-cancer related lymphedema (BCRL)

OTHER

Device: User of Dayspring device

Interventions

User of Dayspring device DEVICE

The Dayspring™ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential compression system.

Breast-cancer related lymphedema (BCRL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koya Medical, Inc.: lead

Study Sites (2)

PT works

Los Altos, California, 94024, United States

Location

Ginger-K Lymphedema & Cancer Center

Morgan Hill, California, 95037, United States

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stanley G Rockson, MD

  Medical Advisor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: December 9, 2020
• Study Start: August 5, 2020
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Locations

US (2)