French-based medical equipment firm Theraclion has begun treatment in the US pivotal clinical study of Echopulse echotherapy to treat patients with breast fibroadenomas (BFAs).
Equipped with the echotherapy technology, the Echopulse combines high-intensity focused ultrasound (HIFU) for therapy and real-time ultrasound imaging for monitoring.
This combination characteristic of the device is claimed to enable precise, individualised, non invasive and outpatient treatment of breast fibroadenomas.
Expected to enroll approximately 100 patients, the clinical trial is designed to evaluate the safety and efficacy of Echopulse as a non-invasive treatment.
Theraclion chief executive officer David Caumartin said: “The US market for non-invasive treatment alternatives for BFA is significant. There are approximately 400 thousand surgeries to remove BFAs in the US each year.
"We believe that patients are searching for alternatives to invasive surgery that are outpatient, of short duration, generate minimal or no post-treatment pain and no scarring.
"This clinical trial is a significant step toward bringing our Echopulse echotherapy to US patients.”
The trial will be conducted at four centres in the US and at one centre in Germany, Europe.
The subjects in the study will receive a single high-intensity ultrasound treatment with Echopulse and the primary endpoint as a decrease in fibroadenoma volume, pain and anxiety will be determined.
Echopulse is claimed to provide millimetric accuracy during treatment and high-quality image. It is expected that the HIFU technology of the device will offer the patients with an alternative to surgery and an opportunity to avoid scar.
Theraclion has secured the CE mark for non-invasive ablation of breast fibroadenomas and thyroid nodules.
Image: Histopathologic image of breast fibroadenoma. Photo: courtesy of KGH / Wikipedia.