South Miami Hospital Fibroid Registry
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|ClinicalTrials.gov Identifier: NCT02362009|
Recruitment Status : Terminated (Policy approved describing all procedures as standard of care)
First Posted : February 12, 2015
Last Update Posted : March 31, 2017
|Condition or disease|
|Uterine Myomas, Leiomyomas, or Fibromas|
The proposed research will be a prospective registry study of patients treated for uterine fibroids at the Fibroid Center located at South Miami Hospitals Center for Women and Infants.
Our objective is to establish the Fibroid Registry:
- To collect and review short, middle and long term clinical outcomes data that will help inform and facilitate the decision making process of clinicians and patients on the safest and most effective treatment for symptomatic uterine myomas, leiomyomas, or fibromas.
- To be able to critically evaluate the quality of procedures being performed and to ultimately establish a gold standard of care based upon patient and clinical outcomes and characteristics.
- To ultimately establish a gold standard of care based upon clinical outcomes and patient characteristics.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||52 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||South Miami Hospital Fibroid Registry|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
- Short, middle and long term clinical outcomes data that will help inform and facilitate the decision making process of clinicians and patients on the safest and most effective treatment for symptomatic uterine myomas, leiomyomas, or fibromas. [ Time Frame: Data elements will be collected at baseline prior procedure, at follow up for 30 days (± 5 days), 6 months (±5 days) and 12 months (± 5 days) post procedure. ]
- Critically evaluate quality of procedures being performed and ultimately establish a gold standard of care based upon patient, clinical outcomes and characteristics (Fibroid Questionnaire & Quality of Life Questionnaire) [ Time Frame: Baseline prior procedure, at follow up for 30 days (± 5 days), 6 months (±5 days) and 12 months (± 5 days) post procedure. ]
Such registry will enable us to address a number of research questions, for instance:
- Is uterine artery embolization (UAE) a safe treatment for leiomyomata?
- Is UAE an effective treatment for leiomyomata?
- What is the likelihood of symptom relief?
- How durable is the treatment?
- What is the likelihood that a woman who undergoes UAE and plans subsequent pregnancy will be able to conceive and deliver a subsequent intrauterine pregnancy?
- Are women choosing this procedure content with their selection?
- Are there certain patient subgroups at higher risk or that have an increased likelihood of treatment benefits?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362009
|United States, Florida|
|South Miami Hospital|
|Miami, Florida, United States, 33143|
|Principal Investigator:||Jaime Sepulveda, M.D||Principal Investigator|