The Lily Device Trial

The registered record

Accession number

NCT06786078

Lead sponsor

Luminate Medical, Inc. (industry)

Registered condition naming hair loss

Chemotherapy Induced Alopecia

Official title

PREVAIL: a Clinical Investigation on Providing Reduced Effects of Visible Alopecia Caused by Chemotherapy Using the Lily Device - a Safety and Efficacy Study.

Interventions

• DeviceLily Device

Names and types as registered. The sponsors' free-text descriptions of these interventions are not reproduced: they are written by the party with an interest in the result, and reprinting them inside this site's layout would lend them this site's voice.

Design

Study type

interventional

Phase

Not applicable

Allocation

na

Masking

none

Primary purpose

prevention

Enrolment

85 participants (estimated)

Sites

5 locations in United States

What it measures

1. 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)

2. Primary Safety Endpoint - Subject incidence of Grade 1 or above ADE, graded with Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

   Time frame: From enrollment in the study until the end of study visit, taking place 30 days after the last treatment visit

Primary outcome measures only, as registered. What a trial chose to measure, and when, is the most informative thing about it that is knowable before it reports — a hair-count endpoint at 24 weeks and a patient-satisfaction endpoint at 12 weeks are not the same study.

Who can take part

Sex

all

Age

18 Years

Healthy volunteers

not accepted

A summary of three registered fields, not the eligibility criteria. The full inclusion and exclusion criteria, the recruiting sites and the study contacts are on the registry record, which is the only place they are maintained. This site has no relationship with this trial and cannot refer anyone to it.

Registered dates

Study start

20 December 2024 (actual)

Primary completion

July 2025 (estimated)

Study completion

November 2025 (estimated)

First posted

22 January 2025 (actual)

Last update posted

22 January 2025 (actual)

"Estimated" and "actual" are the registry's own labels: an estimated date is a plan, and plans move. A date is printed at the precision it was registered at: a primary completion registered as 2025-07 is a month, and rendering it as 1 July 2025 would invent a day the sponsor did not register.

Results

This trial has not reported results. ClinicalTrials.gov holds no results record for it. That is the ordinary state of a trial that is running or about to run, and it means there is nothing here to tell you about whether the intervention works — including nothing negative. If this page implied otherwise it would be wrong.

On this site

Guides covering the condition this trial is registered for. They are about published evidence; this page is about a registration, and the two do not overlap.

Chemotherapy Hair Loss: Which Drugs Cause It, What Scalp Cooling Achieves, and the Regrowth Timeline

Where this came from

Read from the ClinicalTrials.gov API on 6 September 2026 and rebuilt into this page without alteration. ClinicalTrials.gov is a service of the U.S. National Library of Medicine and is the authority on this record; where this page and the registry disagree, the registry is right. This page is not affiliated with or endorsed by NLM or NIH, or with the sponsor of this trial.

Open NCT06786078 on ClinicalTrials.gov · All 157 trials in the pipeline