30 closest matches · ranked by relevance
Leiomyoma
Primary: Shrinkage of Fibroids - Size of Fibroids — -0.27; -0.18; 0.07 logcm3 — p=0.43
Recurrent Pregnancy Loss · Unexplained Infertility
Primary: Abnormal Microbiome Bacterial Sequencing
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
Intrauterine Adhesion
Primary: Safety (Adverse Events) — 0 device related adverse event
Uterine Fibroids · Adhesions
Primary: Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids — 34 Participants
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
Sarcoma
Primary: Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 — 2; 0 participants
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…
Asherman's Syndrome
Primary: Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group — 12; 22 participants — p=0.009
Uterine Fibroids (Leiomyomas)
Primary: Evaluation of All Adverse Events Encountered — 0; 0.95 Adverse Device Effects / patient
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
Intrauterine Growth Restriction · Villitis · IUGR
Primary: Number of Participants With Uterine Artery Indices Completed — 13; 3 Participants
Metrorrhagia
Primary: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms — 0.295; 0.012 Proportion of participants — p=< 0.0001
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…
Metrorrhagia
Primary: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms — 0.292; 0.029 Proportion of participants — p=< 0.0001
Leiomyoma · Uterine Fibroids
Primary: Changes in Fibroid-related Symptoms After Treatment With Letrozole — -10.42; 1.43 units on a scale — p=0.24
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…
Infertility
Primary: Measurement of Uterine Artery Pulsatility Index — 2.40; 2.35 index — p=<0.05
Leiomyoma
Primary: Number and Type of Adverse Events — 15 Adverse Events
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
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
Endometrial Adenocarcinoma · Endometrial Adenosquamous Carcinoma · Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation
Primary: Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor…
Uterine Fibroids
Primary: Change From Baseline in Vaginal Bleeding — -83.5; -36.0; -63.5; -39.5 mL
Uterine Scar · Cesarean Section Complications · Cesarean Section; Dehiscence
Primary: Number of Participants With Niche Visualized by Saline Infusion Sonography — 40; 53; 25; 23 Participants — p=0.05
Postpartum Hemorrhage · Uterine Atony
Primary: Blood Loss — 616; 418; 141; 106 cc
Asherman Syndrome
Primary: the AFS Score at Second-look Hysteroscopy — 1.6; 1.9 units on a scale — p=>0.05
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
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
Recurrent Uterine Sarcoma · Uterine Carcinosarcoma
Primary: Progression-free Survival (PFS) > 6 Months — 4.3 percentage of participants