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EDAP Announces Interim Results from Phase 3 Study Evaluating Robotic HIFU for the Treatment of Deep Infiltrating Endometriosis
EDAP TMS SA (Nasdaq: EDAP) announced interim results from its Phase 3 study evaluating robotic High-Intensity Focused Ultrasound (HIFU) therapy for deep infiltrating endometriosis.
The study, involving 60 patients, aimed to assess acute pelvic pain levels. Key findings include:
1. Robotic HIFU therapy maintained an excellent safety profile, confirming results from earlier studies.
2. The primary endpoint of reduced acute pelvic pain in the HIFU arm compared to the Sham arm was not met at three months.
3. Both arms showed significant reduction in pelvic pain scores from baseline.
4. HIFU-treated patients experienced higher volume reductions in endometriosis nodules compared to the Sham arm.
5. The study continues, with Sham arm patients electing HIFU therapy after pain returned to baseline.
1. Robotic HIFU therapy maintained an excellent safety profile, confirming results from earlier studies.
2. The primary endpoint of reduced acute pelvic pain in the HIFU arm compared to the Sham arm was not met at three months.
3. Both arms showed significant reduction in pelvic pain scores from baseline.
4. HIFU-treated patients experienced higher volume reductions in endometriosis nodules compared to the Sham arm.
5. The study continues, with Sham arm patients electing HIFU therapy after pain returned to baseline.
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