Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT02884960
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine fibroids. A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. Symptom severity, health-related quality of life, and the appearance of the fibroids will be assessed prior to treatment. Patients will then undergo the uterine fibroid embolization procedure with either Embosphere Microspheres or Embozene Microspheres, which will be randomly assigned. Clinical outcomes will be assessed 1 month, 3 months, 6 months and 12 months after the procedure, and imaging outcomes will be obtained 3 months after the procedure.
Detailed Description:
The uterine fibroid embolization (UFE) procedure is an accepted, minimally invasive treatment option for patients with symptomatic uterine fibroids. Studies evaluating the outcomes after this procedure have established that the use of polyvinyl alcohol particles and Embosphere Microspheres is associated with best clinical and imaging outcomes. Embozene Microspheres represent a new embolic agent that is being evaluated for use for the treatment of symptomatic fibroids. The purpose of this study is to evaluate the safety and effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine fibroids.
A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. A questionnaire designed to assess symptom severity and health-related quality of life in patients will be administered to patients at the time of enrollment. In addition, a contrast-enhanced magnetic resonance imaging (MRI) examination will be performed to confirm the diagnosis of fibroids. Patients will then undergo the uterine fibroid embolization procedure. The embolic agent used for the procedure (Embosphere Microspheres or Embozene Microspheres) will be randomly assigned. Patients will be seen 1 month, 3 months, and 6 months and contacted 12 months after the procedure so that the same questionnaire can be used to assess clinical outcomes. In addition, an MRI will be performed 3 months after the procedure to determine the imaging response to treatment.
Study:
NCT02884960
Study Brief:
Protocol Section:
NCT02884960