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NCT06786078 · ClinicalTrials.gov registry record · NA
The Lily Device Trial
A NA study of Chemotherapy-induced Alopecia, sponsored by Luminate Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 85
- Enrollment target
- 5
- Study locations
NCT06786078: Recruiting NA study of Chemotherapy-induced Alopecia, sponsored by Luminate Medical.
NCT06786078 is a NA study of Chemotherapy-induced Alopecia that is actively recruiting participants, run by Luminate Medical. The registered enrollment target is 85 participants, above the 72-participant average among 4 other Chemotherapy-induced Alopecia trials with a reported enrollment target (18% higher). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06786078, a NA study of Chemotherapy-induced Alopecia, is actively recruiting participants, sponsored by Luminate Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 85 participants
- Enrollment target
- 5
- Study locations
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)?
Primary Outcome
A cycle of chemotherapy relates to the delivery of the chemotherapy regimen. In particular: * Participants on regimens delivered every 3 weeks - 1 chemotherapy treatment = 1 cycle. * Participants on regimens delivered every 2 weeks - 1 chemotherapy treatment = 1 cycle. * Participants on regimens delivered every 1 week - 3 chemotherapy treatments = 1 cycle. In CTCAE v5.0 alopecia grades are described as below: * Grade 0: No hair loss * Grade 1: Hair loss of \<50% of normal for that individual
Conditions Studied
Interventions
- DEVICE Lily Device
Study Locations (5)
New Jersey
- Inspira Health - Mullica Hills - Mullica Hill
- Inspire Health - Vineland - Vineland
New York
- Guthrie - Our Lady of Lourdes Memorial Hospital - Binghamton
- Clinical Research Alliance - Westbury
Pennsylvania
- Guthrie Sayer Medical Centre - Sayre
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2024-12-20 |
| Est. Completion | 2025-11 |
| Phase | NA |
What NCT06786078 shows while recruiting
NCT06786078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 72-participant average among 4 other Chemotherapy-induced Alopecia trials with a reported enrollment target (18% higher).
The record links to 1 condition, with Chemotherapy-induced Alopecia appearing as the primary indexed condition, and to 1 intervention - of which Lily Device is the first listed.
NCT06786078 lists 5 locations in 3 states (New Jersey, New York, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT06786078 about?
NCT06786078 is a clinical study titled "The Lily Device Trial". 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 chemoth...
What is the current status of trial NCT06786078?
This trial is currently recruiting. It is a NA study. The enrollment target is 85 participants. The study started on 2024-12-20. Estimated completion is 2025-11.
What conditions does trial NCT06786078 study?
This clinical trial studies the following conditions: Chemotherapy-induced Alopecia.
What interventions are being tested in trial NCT06786078?
The interventions under investigation include: Lily Device (DEVICE).
Who is sponsoring clinical trial NCT06786078?
This trial is sponsored by Luminate Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06786078 being conducted?
This trial has 5 study locations across New Jersey, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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