30 closest matches · ranked by relevance
Uterine Diseases
Primary: Successful Removal of the Uterus Without Conversion to Another Technique — 35; 35 Participants — p=0.0221
Pelvic Organ Prolapse
Primary: Number of Participants With Recurrence of Pelvic Organ Prolapse — 0; 0 Participants
Cervical Cancer
Primary: Pelvic Recurrence Rate at 3 Years — 2.17; 2.52 percentage of participants
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
Menorrhagia
Primary: HRQoL (Health Related Quality of Life) — 0.08; 0.10 points on a scale
Adenomyosis
Primary: Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis — 9; 8; 7; 6 treated areas
Leiomyoma
Primary: Number and Type of Adverse Events — 15 Adverse Events
Uterine Fibroids (Leiomyomas)
Primary: Evaluation of All Adverse Events Encountered — 0; 0.95 Adverse Device Effects / patient
Uterine Fibroids
Primary: Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids — 2.6 Adverse Event/subject
Urinary Retention · Voiding Disorders
Primary: Number of Participants With Void Trial Failure Rate — 7; 11 Participants
Uterine Fibroids · Leiomyoma · Menorrhagia
Primary: Number of Adverse Events — 1 Participants
Leiomyomata
Primary: Number of Participants With Serious Adverse Events — 0; 0 Participants
Endometrial Cancer
Primary: Health Related Quality of Life (HRQoL) — 0.34; 0.30; 0.66; 0.48 scores on a scale — p=0.011
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
Myoma
Primary: Operation Time — 146.1; 124.6 seconds
Pain, Postoperative
Primary: Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME) — 2.00; 5.32 morphine milligram equivalents (MME)
Menorrhagia
Primary: Success (Reduction in Menstruation to Normal Levels) — 59 Participants — p=.271
Placenta Accreta
Primary: Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study. — 60 Participants
Benign Disease Where Total Hysterectomy is Indicated
Primary: Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side. — 97.5 percentage of participants
Uterine Fibroids · Polyps
Primary: Percent Reduction in Target Pathology Volume — 96.9; 99.9 percentage of fibriods/polyps
Heavy Menstrual Bleeding
Primary: Hot Flush Frequency Total Score (HFRS) Change — 9.3; 8.8; 12.7 score on a scale
Uterovaginal Prolapse
Primary: Cumulative Failure — 78; 69; 9; 16 Participants
Cervical Cancer · Uterine Endometrial Cancer · Ovarian Cancer
Primary: Hospital Stay — 3.0; 3.0 Days — p=0.36
Pain · Hysterectomy · Myomectomy
Primary: Quality of Surgical Field Visualization — 9; 1; 5; 2 participants
Benign Uterine Disease
Primary: The Primary Endpoint of This Study is Time Difference Between Cauterizing One Side of the Uterine Attachments, From the Round Ligament to the Uterine Artery on One Side…
Uterine Fibroids · Polyps
Primary: Procedure Efficacy — 95.4 percent of pathology
Menorrhagia
Primary: Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC). — 15; 0 units on a scale — p=0.003
Pelvic Organ Prolapse
Primary: Proportion of Patients Having Concurrent Apical Suspension Performed — 66 Participants
Abnormal Uterine Bleeding · Infertility
Primary: Percentage of Tissue Removed — 97.5 Percentage of tissue removed
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…