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Clinical Outcomes and Patient Satisfaction With Use of the Amma System

NCT05508984 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2026-04-24

No results posted yet for this study

Summary

The primary goal is to conduct a pilot evaluation of the Amma device, to determine whether it is feasible to offer as an option for patients within oncology suites within the PH\&S system.

Conditions

Interventions

DEVICE

Amma Cooling Caps

Once enrolled, subjects will be provided the Amma device by the clinic on days of chemotherapy treatment, and upon completion of treatment it will be returned to the clinic for safekeeping. Upon completion of chemotherapy, anywhere from 3-6 weeks following treatment, subjects will repeat the questionnaires and their hair will be photographed again. The overall duration of the study for subjects will be anywhere from 4 months to 8 months, depending on the duration of their chemotherapy regimen.

Sponsors & Collaborators

  • Cooler Heads

    collaborator UNKNOWN

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • David Page, MD · Providence Health & Services

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2024-01-24
Completion
2026-12-31
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 NCT05508984 on ClinicalTrials.gov