NCT07142304

The Lilac Device Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Luminate Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chemotherapy Induced Peripheral Neuropathy (CIPN)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-03
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2025-08-26
• Last updated: 2026-04-02

Locations

15 sites across 2 countries: United States, Ireland