30 closest matches · ranked by relevance
Leiomyoma
Primary: Shrinkage of Fibroids - Size of Fibroids — -0.27; -0.18; 0.07 logcm3 — p=0.43
Uterine Fibroids
Primary: Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids — 2.6 Adverse Event/subject
Uterine Fibroids (Leiomyomas)
Primary: Evaluation of All Adverse Events Encountered — 0; 0.95 Adverse Device Effects / patient
Leiomyoma
Primary: Number and Type of Adverse Events — 15 Adverse Events
Menorrhagia
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
Leiomyoma
Primary: mg Equivalent Morphine Used Until Discharge From Recovery Room to Control Pain Level Below 4/10 (VAS) — 11; 5.1 mg
Uterine Fibroids · Uterine Myomas
Primary: Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure — 40.2; 48.8; 59.1; 67.7 Percentage of participants
Leiomyoma
Primary: Uterine Volume — 719; 449 mL
Uterine Fibroids · Uterine Leiomyomata
Primary: Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids — 1.3 treatment-related AE/patient
Leiomyoma
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…
Uterine Fibroids
Primary: Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment — 0 Percentage of participants
Uterine Leiomyoma · Uterine Fibroids
Primary: Number of Adverse Events — 77; 75 Adverse Events
Leiomyoma · Uterine Fibroids
Primary: Changes in Fibroid-related Symptoms After Treatment With Letrozole — -10.42; 1.43 units on a scale — p=0.24
Leiomyoma · Uterine Hemorrhage
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
Leiomyoma · Uterine Hemorrhage
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
Uterine Myomas
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…
Uterine Fibroids
Primary: Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses — 48.7; 60.5 percentage of subjects
Uterine Fibroids · Leiomyoma · Menorrhagia
Primary: Number of Adverse Events — 1 Participants
Heavy Uterine Bleeding · Uterine Fibroids
Primary: Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) — 213.70; 269.36; 321.73; 335.11 mL — p=< 0.001
Leiomyomata
Primary: Number of Participants With Serious Adverse Events — 0; 0 Participants
Uterine Myomas
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…
Abnormal Uterine Bleeding · Infertility
Primary: Percentage of Tissue Removed — 97.5 Percentage of tissue removed
Heavy Uterine Bleeding · Uterine Fibroids
Primary: Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month…
Uterine Fibroids
Primary: Change From Baseline in Vaginal Bleeding — -83.5; -36.0; -63.5; -39.5 mL
Uterine Fibroids
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
Leiomyoma · Uterine Fibroids · Uterine Neoplasms
Primary: Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI) — 29; 29 participants
Uterine Fibroids
Primary: Percent Occurrence of Chronic Leg Pain — 97 percentage of subjects without leg pain
Adenomyosis
Primary: Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis — 9; 8; 7; 6 treated areas
Uterine Fibroids · Adhesions
Primary: Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids — 34 Participants
Uterine Fibroids
Primary: Percentage of Participants in Amenorrhea at the End of Treatment Course 1 — 0.0; 53.8; 46.7 percentage of participants — p=0.0019