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The Lily Device Trial

NCT06786078 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2025-01-22

No results posted yet for this study

Summary

The goal of this clinical trial is to test if the Lily Device works to reduce chemotherapy induced hair loss in patients. It will also learn about the safety of the Lily Device. The main questions it aims to answer is:

* Do patient preserve their hair using the Lily Device after 4 cycles of chemotherapy, when hair preservation is a Grade ≤1 graded by an independent healthcare professional on the Common Terminology Criteria for Adverse Events (CTCAE)?
* What is the subject incidence of Grade 1 or above Adverse Device Events (ADE's)?

Conditions

  • Chemotherapy Induced Alopecia

Interventions

DEVICE

Lily Device

Participants will wear the Lily Device at each chemotherapy session for the prescribed duration, where the device must be used during infusion and for at least two (2) hours and up to four (4) hours post infusion.

Sponsors & Collaborators

  • Luminate Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-20
Primary Completion
2025-07-31
Completion
2025-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06786078 on ClinicalTrials.gov