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 (TIGRIS)

May 18, 2021 updated by: Koya Medical, Inc.
To evaluate the Dayspring Active Wearable Compression Technology in enhancing lymph movement and its safety and effectiveness after lymphatic surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Dung Nguyen, MD, PharmD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 upper extremity edema and have or will undergo lymphatic surgery with Dr. Nguyen
  • Subjects must have a difference in volume greater than 3% between the limbs.

Exclusion Criteria:

  • 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
  • Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
  • Diagnosis of lipedema
  • Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior to admittance into the study
  • Diagnosis of acute thrombophlebitis (in last 2 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
  • Diagnosis of epilepsy
  • Patients with poorly controlled asthma
  • 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
  • Bilateral limb edema

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery
Device: Dayspring Active Wearable Compression System
Dayspring Active Wearable Compression System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICG Fluorescence Lymphatic Imaging
Time Frame: Baseline and at Day 28
ICG fluorescence lymphatic imaging evaluates for changes in lymphatic drainage of the limb. ICG is a water soluble tricarbocyanine dye, has a short plasma half life of 3 to 5 minutes in humans, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. ICG contains sodium iodide and is recommended by manufacturer to be used with caution in patients who have a history of allergy to iodides, although type-I allergic reaction (anaphylaxis) cannot really occur because iodine is a chemical element that is an essential component of the human body.
Baseline and at Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koya Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

May 12, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCT 005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphedema

Clinical Trials on Dayspring Active Wearable Compression System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe