Uterine Leiomyoma Clinical Trial
Official title:
Directed Ablation of Uterine Fibroids Using a Noninvasive Approach (DIANA)
The purpose of this clinical study is to assess the safety and effectiveness of the Mirabilis System for treating uterine fibroids in women who are seeking relief from fibroid-related abnormal uterine bleeding but want to avoid hysterectomies or other surgical procedures. The Mirabilis System is an investigational device that delivers high-intensity focused ultrasound (HIFU) to the uterus using integrated ultrasound imaging guidance to offer noninvasive treatment for uterine fibroids. With the Mirabilis System, HIFU is applied noninvasively through the skin using an applicator that is placed against the abdomen. No incisions or surgical procedures are required. During this study, eligible patients will have one or more fibroids treated with the Mirabilis System and will then remain in the study for a total of 36 months after treatment to monitor the occurrence of adverse events. Primary endpoints will be assessed at 12 months after treatment, while secondary endpoints will be assessed at variable times ranging from immediately after treatment up to 36 months after treatment.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04519593 -
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
|
N/A | |
| Completed |
NCT01338831 -
Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer
|
Phase 1 | |
| Completed |
NCT01468402 -
Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma
|
N/A | |
| Completed |
NCT03847077 -
Trial of a Patient Education Tool For Leiomyoma
|
N/A | |
| Completed |
NCT00365989 -
MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
|
Phase 3 | |
| Completed |
NCT03751124 -
Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
|
Phase 3 | |
| Recruiting |
NCT02495311 -
The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms
|
||
| Completed |
NCT00332033 -
Development of a Non-Invasive Treatment for Uterine Leiomyoma (Fibroids)
|
Phase 2 | |
| Completed |
NCT04874246 -
Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy
|
N/A | |
| Not yet recruiting |
NCT04282863 -
Comparison Between Robotic (RM) and Laparoscopic Myomectomy (LM)
|
N/A | |
| Recruiting |
NCT06115408 -
Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma
|
Phase 2/Phase 3 | |
| Completed |
NCT02049242 -
Uterine Tourniquet at Open Myomectomy
|
N/A | |
| Completed |
NCT02059954 -
Vaginal vs. Laparoscopic Hysterectomy
|
N/A | |
| Terminated |
NCT01738724 -
Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin
|
Phase 4 | |
| Terminated |
NCT01280045 -
Influence of Aromatase Inhibitors and GnRH Analogs to Treat Uterine Leiomyoma by Vaginal Hysterectomy
|
N/A | |
| Withdrawn |
NCT02736435 -
Treatment of Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound
|
Phase 3 | |
| Completed |
NCT04819633 -
Evaluating Serum Sestrin in Leiomyoma Patients
|
||
| Completed |
NCT00341848 -
Postpartum Uterine Regression
|
||
| Completed |
NCT01715597 -
Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma
|
Phase 3 | |
| Completed |
NCT03328260 -
High Intensity Focused Ultrasound in Uterine Myoma
|
N/A |