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Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss

NCT05484973 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2025-04-06

No results posted yet for this study

Summary

The purpose of this prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer. Additionally, the purpose is also to assess the safety, tolerability and compliance, quality of life, and satisfaction with hair preservation after CT treatment.

Conditions

Interventions

DEVICE

AMMA Portalbe Scalp Cooling System

AMMA Portalbe Scalp Cooling System AMMA is indicated for use in chemotherapy infusion centers, during transit from the infusion center andat home and is intended for use by patients who are undergoing chemotherapy treatment and who want to reduce the likelihood of chemotherapy-induced alopecia.

Sponsors & Collaborators

  • Cooler Heads Care Inc.

    lead OTHER_GOV

Principal Investigators

  • Kate Dilligan · Cooler Heads Inc.

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-08
Primary Completion
2026-03-31
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05484973 on ClinicalTrials.gov