A Prospective Non-randomized, Open-label Study (TIBER) to Evaluate the Safety and Effectiveness of a non-pneumatic compression device (NPCD) for Treating Lower Limb Lymphedema

Saturday, October 15, 2022

9:35 AM – 9:48 AM US CDT

Location: Celestin D/E (Live Stream)

Presenting Author(s)

Stanley G. Rockson, MD

Allan and Tina Neill Professor of Lymphatic Research and Medicine
Stanford University School of Medicine
Stanford University
STANFORD, California

Disclosure: Koya Medical, Inc. (Self): Consultant/Advisory Board

PDF Slides

Co-Author(s)

PK

Pinar Karaca-Madic

Disclosure: Disclosure information not submitted.
HH

Heather Hettrick, PhD

Disclosure: Disclosure information not submitted.

Introduction, Objectives, and/or Purpose: To evaluate the non-pneumatic compression device (NPCD) for the treatment of lymphedema of the lower extremities.

Methods: Up to 24 subjects with lymphedema of the lower extremity were enrolled across two sites. All subjects received the non-pneumatic compression device garment as their daily at-home treatment. Limb volume, LYMQOL, and adherence to daily therapy were measured.

Results: 18 subjects completed the study and 6 were lost to follow up. The subjects were overwhelmingly female (17/24). Average age was 63± 14 years, expressed as mean ± standard deviation. Of the participants, all were diagnosed with lymphedema from cancer or from chronic venous insufficiency. No device-related adverse events were reported during the study. After 3 months of use, subjects had a statistically significant (p < 0.05) improvement in overall QoL as measured by the Lymphedema Quality-of-Life Questionnaire compared with baseline. Individual QoL domains, and limb volume improved (up to 40% reduction in edema) with therapy.

Conclusion(s): The non-pneumatic compression device (NPCD) demonstrated improvement in QoL outcomes and improvement in edema volume reduction over the period of evaluation. Subjects found the device easy to use, mobile during treatment, addressing a potential barrier to adherence with commercially available pneumatic compression devices (PCDs).