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RECRUITING
NCT07142304
NA

The Lilac Device Trial

Sponsor: Luminate Medical, Inc.

View on ClinicalTrials.gov

Summary

Chemotherapy drugs, used in the treatment of cancer, have the potential of inducing peripheral neuropathy (PN) as a side effect. This side effect is commonly referred to as CIPN, or chemotherapy-induced peripheral neuropathy. The Lilac Glove and Boot devices apply a low pressure across the surface of the hands and feet, respectively, to reduce access of chemotherapy to the peripheral nerves on the hands and feet. The small amount of pressure reduces the level of chemotherapy reaching the peripheral nerves, hence increasing the likelihood of nerve preservation during treatment and thus may potentially temporarily prevent the onset of moderate to severe PN symptoms induced by chemotherapy in the hands and feet while receiving treatment

Official title: IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2025-10-03

Completion Date

2026-10

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DEVICE

The Lilac Device

The Lilac Glove and Boot devices are wearable, non-sterile device for patients undergoing cancer treatment who wish to reduce the risk of peripheral neuropathy. Treatment with the Lilac Glove and Boot devices is administered by the healthcare professional in the healthcare environment. The Lilac Glove and Boot devices are designed for continual use; the devices must be fitted and turned on before infusion begins; the devices must be used without interruption during infusion, and for up to two (2) hours after infusion is complete.

DEVICE

Sham device

The sham device will look, appear to function and worn for the same duration as the Lilac Device. The only difference between the devices is the level of compression applied.

Locations (15)

Palomar Health (Topography)

Poway, California, United States

Eastern Connecticut Hematology Oncology

Norwich, Connecticut, United States

Hialeah Hospital

Hialeah, Florida, United States

Hawaii Cancer Care

Honolulu, Hawaii, United States

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

Parkview Cancer Institute

Fort Wayne, Indiana, United States

Health Partners Frauenshuh Cancer Center

Minneapolis, Minnesota, United States

Fairview Masonic Cancer Clinic, University of Minnesota

Minneapolis, Minnesota, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

New York Cancer and Blood Specialists

New York, New York, United States

Springfield Regional Cancer Center

Springfield, Ohio, United States

Mercy Health St. Elizabeth Hospital

Youngstown, Ohio, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Hospital Sisters Health System - St.Vincent & St.Mary's

Green Bay, Wisconsin, United States

St. James Hospital

Dublin, Dublin, Ireland