Overview
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
Description
6. Clinical Hypotheses
- The Insight Pro device can detect a difference in extracellular fluid volume through bioimpedance and dielectric constant measurement.
- The Insight Pro device can detect a difference in skin hardness or fibrositis through a durometer measurement.
- The Insight Pro device is safe for use as assessed by adverse events.
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