NCT05508984

Clinical Outcomes and Patient Satisfaction With Use of the Amma System

Observational Study of Clinical Outcomes and Patient Satisfaction With Use of the Amma System

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A novel cold capping device, named Amma™, is now commercially available for use and FDA approved. The Amma system has the potential to be as effective as the Penguin Cold Cap system, but with key innovations that make it more efficient and feasible in the clinic. Innovations include: * Portable and battery powered unit, not requiring dry ice * Form-fitting scalp cap that eliminates the need for frequent cap exchanges The Amma system has not been evaluated for efficacy, and no clinical trials are published. Because of the ease of use and the self-directed administration of the Amma scalp cooling device, we wish to explore this as an option for patients treated within the PH\&S system. To do this, we propose an observational study that evaluates clinical outcomes and patient-reported satisfaction amongst a cohort of patients who undergo self-directed scalp cooling using the Amma system.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-22
• Primary completion: 2024-01-24
• Completion: 2025-12-01
• First posted: 2022-08-19
• Last updated: 2025-03-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study