Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

South Miami Hospital Fibroid Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Jaime Sepulveda, 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.

Condition or disease
Uterine Myomas, Leiomyomas, or Fibromas

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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?



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatients seen for fibroid treatment services.
Criteria

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.


Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Florida
South Miami Hospital
Miami, Florida, United States, 33143
Sponsors and Collaborators
Baptist Health South Florida
Investigators
Layout table for investigator information
Principal Investigator: Jaime Sepulveda, M.D Principal Investigator
Additional Information:

Layout table for additonal information
Responsible Party: Jaime Sepulveda, MD, Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT02362009    
Other Study ID Numbers: 13-099
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Keywords provided by Jaime Sepulveda, Baptist Health South Florida:
Myomas
Leiomyomas
Fibromas
Additional relevant MeSH terms:
Layout table for MeSH terms
Leiomyoma
Myofibroma
Fibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Neoplasms, Fibrous Tissue