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 (NILE)

Koya Medical

Status: Completed

Conditions: Lymphedema of Upper Arm; Lymphedema, Breast Cancer; Lymphedema

Treatments: Device: Crossover Device (PCD or Dayspring - alternate to first group)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04908254

KCT003

Details and patient eligibility

About

To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD)

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Dayspring Active Wearable Compression Device

Experimental group

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.

Treatment:

Device: Crossover Device (PCD or Dayspring - alternate to first group)

Advanced Pneumatic Compression Device

Active Comparator group

Description:

A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device.

Treatment:

Device: Crossover Device (PCD or Dayspring - alternate to first group)