Last updated: May 18, 2021
Sponsor: Koya Medical, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Lymphedema
Treatment
N/AClinical Study ID
NCT04888975
KCT 005
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Males and females ≥ 18 years of age
- Willing to sign the informed consent and deemed capable of following the studyprotocol
- Subjects must have a diagnosis of upper extremity edema and have or will undergolymphatic surgery with Dr. Nguyen
- Subjects must have a difference in volume greater than 3% between the limbs.
Exclusion
Exclusion Criteria:
- Individuals with a history or presence of a systemic disorder or condition that couldplace the patient at increased risk from sequential compression therapy
- Inability or unwillingness to participate in all aspects of study protocol and/orinability to provide informed consent
- Patients with exam results that would prevent safe and effective use of the studydevice (cellulitis, open-wounds, healing-wounds, etc.)
- Diagnosis of active or recurrent cancer, or less than 3 months at the time of initialevaluation from the completion of chemotherapy, radiation therapy or primary surgeryfor the treatment of cancer
- Patients must not have any diagnosed cognitive or physical impairment that wouldinterfere with use of the device
- Diagnosis of lipedema
- Diagnosis of acute infection. The source of the infection must be treated for 2 weeksprior 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 duringthe past 30 days
- Bilateral limb edema
Study Design
Total Participants: 20
Study Start date:
June 01, 2021
Estimated Completion Date:
December 31, 2021
Study Description
Connect with a study center
Dung Nguyen, MD, PharmD
Palo Alto, California 94304
United StatesActive - Recruiting
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