South Miami Hospital Fibroid Registry

NCT ID: NCT02362009

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Uterine Myomas, Leiomyomas, or Fibromas

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Baptist Health South Florida

OTHER

Sponsor Role lead

Responsible Party

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Jaime Sepulveda

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Sepulveda, M.D

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

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South Miami Hospital

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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13-099

Identifier Type: -

Identifier Source: org_study_id

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