South Miami Hospital Fibroid Registry

Terminated

• Conditions: Uterine Myomas, Leiomyomas, or Fibromas

• Registration Number: NCT02362009
• Lead Sponsor: Baptist Health South Florida

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2015-01-20
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-07
• Study First Posted: 2015-02-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 52

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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)	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?

Trial Locations

Locations (1)

South Miami Hospital; 🇺🇸 Miami, Florida, United States