Trials / Recruiting
RecruitingNCT07218432
A Study of the TheraBionic P1 Device in Breast Cancer
A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Barbara Ann Karmanos Cancer Institute · Academic / Other
- Sex
- Female
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect the pathological response.
Conditions
- Breast Cancer Stage I
- Breast Cancer Stage II
- Breast Cancer Stage IIIA
- Hormone Receptor Positive Tumor
- HER2-negative Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TheraBionic P1 Device | Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day and in the evening prior to surgical resection of early stage breast cancer. |
Timeline
- Start date
- 2026-10-01
- Primary completion
- 2027-04-30
- Completion
- 2028-06-30
- First posted
- 2025-10-20
- Last updated
- 2025-12-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07218432. Inclusion in this directory is not an endorsement.