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A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads

NCT05365243 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-08-15

No results posted yet for this study

Summary

Eligible patients will be recruited prior to initiation of chemotherapy for any stage breast or gynecologic cancer. Patients will undergo training in the use of the AMMA Portable Scalp Cooling System and will use the device during each of their chemotherapy treatments. Quality of life and experience of use questionnaires will be completed. Scalp photos and an assessment of hair loss will be preformed at enrollment and at the end of study participation.

Conditions

Interventions

DEVICE

AMMA Portalbe Scalp Cooling System

AMMA is indicated for use in chemotherapy infusion centers, during transit from the infusion center and at 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 Care 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
2022-08-15
Primary Completion
2023-06-30
Completion
2023-09-30
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 NCT05365243 on ClinicalTrials.gov