Clinical Trial

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

Study acronym: IMPACT
Recruiting
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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
Protocol Amendment History 4 changes
notable Trial sites expanded: 15 -> 18 locations 2026-06-11
notable Primary completion pushed: 2026-04 -> 2026-08 2026-06-11
notable Trial sites expanded: 8 -> 15 locations 2026-04-03
notable Primary completion pushed: 2026-03 -> 2026-04 2026-04-03
Trial Details
NCT Number NCT07142304
Lead Sponsor Luminate Medical, Inc.
Conditions Chemotherapy Induced Peripheral Neuropathy (CIPN)
Enrollment 142 participants
Start Date 2025-10-03
Primary Completion 2026-08 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-10