Evaluating the Safety and Effectiveness of the Dayspring Wearable Compression System for Breast Cancer Related Lymphedema After Lymphatic Surgery

What this Trial Is About

This research aims to evaluate the Dayspring Active Wearable Compression Technology in improving lymph flow and to assess its safety and effectiveness in patients who have undergone lymphatic surgery for breast cancer-related lymphedema BCRL. The study focuses on adults diagnosed with upper extremity edema after lymphatic surgery and investigates how this device may help manage symptoms associated with BCRL. Participants will use the Dayspring Active Wearable Compression System, a device designed to enhance lymph movement following lymphatic surgery. The study is open-label and non-randomized, involving patients with breast cancer-related lymphedema who meet specific volume difference criteria between limbs. The intervention period includes baseline assessments and follow-up evaluations at 28 days. During the study, participants will undergo ICG Fluorescence Lymphatic Imaging both at the start and on day 28 to measure lymphatic function. Researchers will monitor safety and effectiveness through these imaging assessments and track participant adherence to device use. The total participation duration includes initial and follow-up visits within the 28-day study period.

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