Current FDA Authorized United States Clinical Trials

TheraBionics has received multiple Investigational Device Exemption (IDE) approvals for clinical trials in the United States related to the Investigational P1 Device from the US FDA.  The studies include:

IDE G200062

TheraBionic P1 Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) Study of Intrabucally Administered Amplitude-Modulated Electromagnetic Fields and Regorafenib as Second-line Therapy for Patients with Advanced Hepatocellular Carcinoma

IDE G200320

TheraBionic P1 Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) Study of Intrabucally Administered Amplitude-Modulated Electromagnetic Fields versus Placebo as Third-line Therapy for Patients with Advanced Hepatocellular Carcinoma [also titled: A Randomized Phase II Study of Intrabucally Administered Electromagnetic Fields Versus Placebo for Patients with Child-Pugh A and B Advanced Hepatocellular Carcinoma]

This study is partially funded by the National Cancer Institutes (NCI) Small Business Innovation Research (SBIR) Program.

IDE G220124

A Multicenter Randomized Phase II Study of Intrabucally Administered Amplitude-Modulated Electromagnetic Fields, Atezolizumab, and Bevacizumab Versus
Placebo Intrabucally Administered Electromagnetic Fields, Atezolizumab, and Bevacizumab as First-line Therapy for Patients with Advanced Hepatocellular Carcinoma

IDE G220167

A Phase 2 Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Metastatic Pancreatic Cancer

The THERABIONIC P1 DEVICE is NOT an FDA-approved device and is for investigational purposes only at this time. Treatment with the device is considered experimental pending clinical trial results and FDA approval in the United States and other regulatory agencies in other countries. 

The device is not available for commercial use.