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

Lymphedema Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04908254
• Other study ID #: KCT003
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Koya Medical, Inc.
• Contact: Stanley G Rockson, MD
• Phone: 4158510337
• Email: info[@]koyamedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema
• Lymphedema of Upper Arm
• Lymphedema, Breast Cancer

Intervention

Device:
• Crossover Device (PCD or Dayspring - alternate to first group)
Cross over arms after a month of use and a month of washout period

Locations

Country	Name	City	State
United States	PT works	Los Altos	California
United States	Ginger-K Lymphedema & Cancer Center	Morgan Hill	California

Sponsors (1)

Lead Sponsor	Collaborator
Koya Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month
Primary	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	1 month
Secondary	Safety/AEs	As assessed by reported adverse events	1 month
Secondary	Therapy adherence tracking	A table will be provided to patient to document days of use with the device to track adherence	1 month
Secondary	Patient survey on preference	A study survey administered at the end of the study to measure patient preference between the two devices	1 month