The Lily Device Trial

Conditions

• Chemotherapy Induced Alopecia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lily Device — 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.

Study Details

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)?

Key Dates

Start date

Dec 20, 2024

Status verified

Jan 2025

Primary completion

Jul 31, 2025

Completion

Nov 30, 2025

Study Design

Enrollment

85 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Intervention

Primary Outcome Measure

Success in hair preservation using the Lily device after 4 cycles of chemotherapy, where hair preservation is defined as CTCAE v5.0 grade ≤ 1 alopecia determined by an independent healthcare professional. [ Time Frame: After 4 cycles of chemotherapy (each cycle is 14 - 21 days dependent on the chemotherapy regimen) ]

Central Contacts

• Kimberly Wilkinson
  +1 (713) 855-3775
  [email protected]

Locations (5)

Find similar trials in Mullica Hill, NJ