Clinical Trial Search

Primary: Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment…

Primary: Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit…

Primary: Changes in Fibroid-related Symptoms After Treatment With Letrozole — -10.42; 1.43 units on a scale — p=0.24

Primary: Percent Reduction in Target Pathology Volume — 96.9; 99.9 percentage of fibriods/polyps

Primary: Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses — 48.7; 60.5 percentage of subjects

Primary: Evaluation of All Adverse Events Encountered — 0; 0.95 Adverse Device Effects / patient

Primary: Shrinkage of Fibroids - Size of Fibroids — -0.27; -0.18; 0.07 logcm3 — p=0.43

Primary: Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids — 2.6 Adverse Event/subject

Primary: Number and Type of Adverse Events — 15 Adverse Events

Primary: Number of Adverse Events — 1 Participants

Primary: Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids — 1.3 treatment-related AE/patient

Primary: Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1 — 0.0; 42.0; 54.8 percentage of participants

Primary: Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment — 1.8; 47.2; 58.3 percentage of participants

Primary: Uterine Volume — 719; 449 mL

Primary: Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC) — 64.8 percentage of participants

Primary: Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment…

Primary: Number of Participants With Serious Adverse Events — 0; 0 Participants

Primary: Procedure Efficacy — 95.4 percent of pathology

Primary: Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure — 40.2; 48.8; 59.1; 67.7 Percentage of participants

Primary: Number of Adverse Events — 77; 75 Adverse Events

Primary: Percentage of Tissue Removed — 97.5 Percentage of tissue removed

Primary: mg Equivalent Morphine Used Until Discharge From Recovery Room to Control Pain Level Below 4/10 (VAS) — 11; 5.1 mg

Primary: Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment — 0 Percentage of participants

Primary: Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids — 34 Participants

Primary: Hemoglobin Levels Difference Between Pre and Post Surgery. — 0.76; 0.93 g/dL

Primary: Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis — 9; 8; 7; 6 treated areas

Primary: Change From Baseline in Vaginal Bleeding — -83.5; -36.0; -63.5; -39.5 mL

Primary: Surgical Blood Loss — 761; 691 ml

Primary: Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 — 2; 0 participants

Primary: Percentage of Participants in Amenorrhea at the End of Treatment Course 1 — 58.33; 70.59; 0.0 percentage of participants — p=0.0008