Clinical evidence | ImpediMed

Clinical evidence

ImpediMed’s bioimpedance spectroscopy (BIS) devices have been studied and clinically validated in the areas of lymphedema, heart failure, body composition and veterinary BIS research.

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L-Dex detection limit
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Andrew J. Accardi, Bradley S. Matsubara, Richelle L. Gaw, Anne Daleiden-Burns, James Thomas Heywood

Clinical Utility of Fluid Assessment in Heart Failure Patients Using Bioimpedance Spectroscopy

Clinical trial compares BIS measurements from patients with heart failure (HF) to those from healthy adults, and describe how these point-of-care fluid volume assessments may be applied to HF management

Open access: Yes
Sutherland, A., Wagner, J.L., Korentager, S. et al. Breast Cancer Research and Treatment

Is bioimpedance spectroscopy a useful tool for objectively assessing lymphovenous bypass surgical outcomes in breast cancer-related lymphedema?

This is the first study to utilize BIS measurements to assess response to LVB surgical intervention for BCRL. BIS measurements demonstrated clinically significant improvement after LVB, providing objective evidence in support of this surgical treatment for BCRL. BIS changes should be reported as key objective data in future studies assessing BCRL interventions, including response to LVB.

Open access: No
National Comprehensive Cancer Network

NCCN Clinical Practice Guidelines in Oncology for Breast Cancer and Survivorship

The NCCN Guidelines® are consistent with regard to the necessity to educate patients about lymphedema and monitor for the early development of lymphedema.

Open access: Yes
John Boyages, MBBS(Hons), FRANCZR PhD, Frank A. Vicini, MD, Chirag Shah, MD, Louise A. Koelmeyer BAppSc, Jerrod A. Nelms PhD, MPH, Sheila H. Ridner, PhD, RN, FAAN

The Risk of Subclinical Breast Cancer–Related Lymphedema by the Extent of Axillary Surgery and Regional Node Irradiation: A Randomized Controlled Trial

The lower triggering rates with BIS and its better discrimination of the risk of sBCRL by receipt and type of RNI compared with TM support its use for post treatment surveillance to detect sBCRL and to initiate early intervention. The risk of sBCRL increased with more extensive axillary treatment. Patients having ALND or extensive RNI require close surveillance for BCRL. Longer follow-up is required to determine rates of progression to clinical lymphedema.

Open access: YES
Chirag Shah, MD, April Zambelli-Weiner, Nicole Delgado, Ashley Sier, Robert Bauserman, Jerrod Nelm

The impact of monitoring techniques on progression to chronic breast cancer‑related lymphedema: a meta‑analysis comparing bioimpedance spectroscopy versus circumferential measurements

Evidence suggests that monitoring with BIS allowing for early intervention significantly reduces the relative risk of chronic BCRL with a 69% and 81% reduction compared to background and circumference, respectively. Circumference monitoring did not appear to provide a benefit with respect to chronic BCRL incidence. Based on these results, BIS should be considered for BCRL screening in order to detect subclinical BCRL and reduce rates of chronic BCRL, particularly in high-risk patients.

Open access: YES
Louise A. Koelmeyer, Leigh C. Ward, Catherine Dean, John Boyages

Body Positional Effects on Bioimpedance Spectroscopy Measurements for Lymphedema Assessment of the Arm

The findings support impedance measurements being made reliably using either the lead or stand- on device, representing supine and upright measurement positions, respectively. Data between devices were, however, not directly interchangeable.

Open access: Yes
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SOZO®

SOZO, the world’s most advanced, noninvasive BIS device, incorporates L-Dex technology to aid in the assessment of secondary lymphedema and delivers a precise snapshot of fluid status and tissue composition in less than 30 seconds.

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