Clinical trial · Observational
South Miami Hospital Fibroid Registry
NCT02362009CI-TRIAL-00026724terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Policy approved describing all procedures as standard of care
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Myomas, Leiomyomas, or Fibromas | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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.
- timeFrame
- 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.
Secondary outcomes (1)
- measure
- 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)
- timeFrame
- Baseline prior procedure, at follow up for 30 days (± 5 days), 6 months (±5 days) and 12 months (± 5 days) post procedure.
- description
- 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?
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients seeking treatment for uterine myomas, leiomyomas, or fibromas. 2. Patients between the ages of 18-89. 3. Patients that agree to participate and sign consent. Exclusion Criteria: 1)Patients that decline to participate and/or are younger than 18 or older than 89.
References
Publications (0)
Data not yet available
No reference posted for this study.