Lymphedema Clinical Trial
— VOLGAOfficial title:
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)
Verified date | February 2024 |
Source | Koya Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | August 28, 2024 |
Est. primary completion date | August 28, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Test group - - Males and females = 18 years of age - Willing to sign the informed consent and deemed capable of following the study protocol - Subjects must have primary or secondary unilateral or bilateral upper or lower extremity edema - At the time of initial evaluation, individuals must be at least 3 months post-surgery, chemotherapy and/or radiation treatment for cancer if applicable Control group - - Males and females = 18 years of age - Willing to sign the informed consent and deemed capable of following the study protocol - Subjects must not have primary or secondary edema and self-describe general healthy Exclusion Criteria: - ? Inability or unwillingness to participate in all aspects of the study protocol and/or failure 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 (< 3 months since completion of chemotherapy, radiation therapy, or primary surgery for the cancer) - Patients with cardiac arrhythmia with pacemakers or other implanted electronic equipment - Patients must not have implanted metal hardware in the limbs - Patients undergoing external defibrillation - Diagnosis of Acute infection (in the last four weeks) - Diagnosis of acute thrombophlebitis (in last 2 months) - Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 2 months - Diagnosis of congestive heart failure (uncontrolled) - Diagnosis of chronic kidney disease with acute renal failure - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Koya Medical, Inc. | Oakland | California |
Lead Sponsor | Collaborator |
---|---|
Koya Medical, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Edema Volume | Edema Volume detection by difference in extracellular fluid volume through bioimpedance and dielectric constant measurement. | Acute - At day 0 | |
Primary | Fibrosis | Durometer detection or Skin hardness (fibrosis) difference through a durometer measurement. | Acute - At day 0 | |
Secondary | Safety/AEs | Safety during use (via adverse event reporting) | Acute - At day 0 | |
Secondary | LymVAS | Correlation with quality-of-life objective parameters using a lymphedema visual analog scale | Acute - At day 0 |
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