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Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)

NCT06215469 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-22

No results posted yet for this study

Summary

The purpose of this post-market, prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer.

Conditions

Interventions

DEVICE

Amma Portable Scalp Cooling System (PSCS)

The unit is a compact, mobile refrigeration unit which circulates liquid coolant at low pressure through a special cooling cap on the participant's head, administered during non-investigational, cancer treatment.

OTHER

Questionnaires

Quality of Life (QoL) and device usage questionnaires

Sponsors & Collaborators

Principal Investigators

  • Jo Chien, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-16
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT06215469 on ClinicalTrials.gov