A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients With Breast Cancer Related Lymphedema (BCRL) After Lymphatic Surgery

Part of paid clinical trials in Palo Alto, California.

Sponsor
Koya Medical, Inc.
Study ID
NCT04888975
Status
Recruiting
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Conditions

  • Lymphedema
  • Lymphedema Arm
  • Lymphedema, Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dayspring Active Wearable Compression System — DEVICE
    Dayspring Active Wearable Compression System

Study Details

To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery

Key Dates

Start date
Jun 1, 2021
Status verified
May 2021
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery
    Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery

Primary Outcome Measure

ICG Fluorescence Lymphatic Imaging [ Time Frame: Baseline and at Day 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dung Nguyen, MD, PharmDPalo AltoCalifornia94304
Dung Nguyen, MD, PharmD
[email protected]
415-851-0337

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Dung Nguyen, MD, PharmD· Palo Alto, CA

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