142 Participants Needed

The Lilac Device for Peripheral Neuropathy

(IMPACT Trial)

Recruiting at 6 trial locations
LK
BO
Overseen ByBarbara Oliveira, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Luminate Medical, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Adults over 18 with solid tumor cancer set for at least 4 cycles of specific chemotherapy regimens (like Oxaliplatin, FOLFIRINOX, Paclitaxel alone or with Carboplatin) can join. It's not for those who need a treatment pause for surgery.

Inclusion Criteria

I am on a chemotherapy regimen that includes Paclitaxel and Carboplatin.
I am set to receive 4 or more chemotherapy cycles without breaks for surgery.
I am receiving FOLFOX treatment every 2 weeks.
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What Are the Treatments Tested in This Trial?

Interventions

  • The Lilac Device

Trial Overview

The trial is testing the Lilac Glove and Boot devices against sham devices to see if they can prevent moderate to severe peripheral neuropathy in hands and feet by reducing chemotherapy exposure to nerves during treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Luminate Medical, Inc.

Lead Sponsor

Trials
1
Recruited
90+