An observational study in Uterine Myomas, Leiomyomas, or Fibromas, sponsored by Baptist Health South Florida. Terminated at 1 site in United States. Open to female participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2017-03-31.
Sponsored by Baptist Health South Florida · Observational
The purpose of the Fibroid Registry is to provide a comprehensive database that captures patient characteristics, clinical outcomes and pot-treatment quality of life measures for patients treated for uterine fibroids. This database will serve as a platform for future comparative effectiveness and other health services research studies.
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:
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
This study's enrollment of 52 is below the median of 150 across 107 observational studies indexed under Leiomyoma.
Browse Leiomyoma studies →Baptist Health South Florida is the lead sponsor of 52 studies on the registry; 18 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Outpatients seen for fibroid treatment services.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1)Patients that decline to participate and/or are younger than 18 or older than 89.
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)
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?
Time frame: Baseline prior procedure, at follow up for 30 days (± 5 days), 6 months (±5 days) and 12 months (± 5 days) post procedure.
The record gives a start of Feb 2015, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Baptist Health South Florida