Actively Recruiting
The Lily Device Trial
Led by Luminate Medical, Inc. · Updated on 2025-01-22
85
Participants Needed
5
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Lily Device Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with stage 1, 2, or 3 breast cancer who have not started systemic therapy
- Planned intravenous chemotherapy with at least 4 cycles using specified regimens including doxorubicin, paclitaxel, or docetaxel
- Head size within the study's specified sizing range
- Plan to complete chemotherapy within 12 months
- Willing and able to sign informed consent
- Willing to comply with study procedures including wearing the Lily Device during and after chemotherapy infusion, completing questionnaires, and having scalp photographs taken
You will not qualify if you...
- Baseline hair loss greater than grade 0 on the CTCAE v5.0 scale
- History of autoimmune diseases causing hair loss such as alopecia areata or systemic lupus
- History of whole brain radiation
- Chemotherapy within the past 2 years that caused hair loss
- Receiving or planning to receive hormone replacement or anti-estrogen therapy known to cause hair loss during the study
- Chemotherapy regimen including taxane and anthracycline agents administered on the same day
- Positive pregnancy test at baseline for participants able to bear children
- Known allergy or sensitivity to any part of the Lily Device
- History of Temporomandibular Joint Disorder
- Open wounds or sores on scalp or face where device will be applied
- Serious infections or medical conditions that prevent completing chemotherapy
- Life-threatening cancers other than the current breast cancer
- Existing or suspected scalp metastases
- Use of other hair loss prevention devices during the study
- Participation in other clinical studies causing hair loss within 30 days before screening
- Previous participation in this study
- Inability to comply with study schedules or procedures due to mental or physical reasons
- Investigator judgement that participant is inappropriate for the study or will not comply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Inspira Health - Mullica Hills
Mullica Hill, New Jersey, United States, 08360
Actively Recruiting
2
Inspire Health - Vineland
Vineland, New Jersey, United States, 08360
Actively Recruiting
3
Guthrie - Our Lady of Lourdes Memorial Hospital
Binghamton, New York, United States, 13905
Actively Recruiting
4
Clinical Research Alliance
Westbury, New York, United States, 11590
Actively Recruiting
5
Guthrie Sayer Medical Centre
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
Research Team
K
Kimberly Wilkinson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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