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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)

Primary Purpose

Lymphedema, Lymphedema, Breast Cancer, Lymphedema Arm

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dayspring Active Wearable Compression System
Sponsored by
Koya Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Dung Nguyen, MD, PharmDRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

ICG Fluorescence Lymphatic Imaging
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.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2021
Last Updated
May 18, 2021
Sponsor
Koya Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04888975
Brief Title
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
Acronym
TIGRIS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koya Medical, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Lymphedema, Breast Cancer, Lymphedema Arm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery
Arm Type
Experimental
Arm Description
Patients with Breast-cancer related lymphedema (BCRL) after lymphatic surgery
Intervention Type
Device
Intervention Name(s)
Dayspring Active Wearable Compression System
Intervention Description
Dayspring Active Wearable Compression System
Primary Outcome Measure Information:
Title
ICG Fluorescence Lymphatic Imaging
Description
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.
Time Frame
Baseline and at Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dung Nguyen, MD, PharmD
Phone
4158510337
Email
info@koyamedical.com
Facility Information:
Facility Name
Dung Nguyen, MD, PharmD
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dung Nguyen, MD, PharmD
Phone
415-851-0337
Email
info@koyamedical.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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