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Focal One high intensity focused ultrasound device · 1 trial · 1 indication
Evaluate the in-field failure-free survival (IFFFS) of localized radiorecurrent prostate cancer patients receiving focal HIFU treatment at 12 months. IFFFS is defined as the absence of biopsy proven clinically significant prostate cancer in the treated zone.
| Arm | Type | Description |
|---|---|---|
| High Intensity Focused Ultrasound | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Focal One high intensity focused ultrasound device | DEVICE | Participants will be treated with one session of high intensity focused ultrasound using the Focal One device. |
Inclusion Criteria: * Patient has elected to undergo focal high intensity focused ultrasound therapy for radiorecurrent prostate cancer * Males who are ≥ 18 years of age * Eastern Cooperative Oncology Group Performance Status of 0-3 * A history of prostate cancer treated with radiation therapy +/- ...
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Focal One high intensity focused ultrasound device is an investigational medical device being studied for the treatment of prostate cancer. It is currently in Phase 2 clinical development. The device uses high intensity focused ultrasound to target prostate cancer tissue. It is being evaluated in a clinical trial in the United States.
Focal One high intensity focused ultrasound device is being developed by EDAP TMS S.A., a biopharmaceutical company. The company's stock is traded under the ticker symbol FOCL. EDAP TMS S.A. is conducting clinical research to evaluate the device for the treatment of prostate cancer.
Focal One high intensity focused ultrasound device is currently in Phase 2 clinical development. It is an investigational device and has not been approved by regulatory authorities. The device is being studied for the treatment of prostate cancer in a Phase 2 clinical trial that is currently recruiting participants.
Focal One high intensity focused ultrasound device is being evaluated in a Phase 2 clinical trial with the identifier NCT06402357. This trial is titled "High Intensity Focused Ultrasound in Prostate Cancer" and is currently recruiting participants in the United States. The trial is expected to enroll 25 male patients aged 18 years and older with prostate cancer.
Focal One high intensity focused ultrasound device is not FDA approved. It is an investigational device currently in Phase 2 clinical development for the treatment of prostate cancer. The device is being studied in a clinical trial to evaluate its safety and effectiveness, but it has not yet received regulatory approval.
Yes, the clinical trial for Focal One high intensity focused ultrasound device is biomarker-selected. The Phase 2 trial NCT06402357 is evaluating the device in patients with prostate cancer, and the study design includes biomarker selection. This means that patient eligibility may be determined based on specific biomarker characteristics.