Uterine Myomas, Leiomyomas, or FibromasNCT02362009
South Miami Hospital Fibroid Registry
An observational study of Uterine Myomas, Leiomyomas, or Fibromas, run by Baptist Health South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Uterine Myomas, Leiomyomas, or Fibromas
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2015
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients seen for fibroid treatment services.
Who may be able to join
- Patients seeking treatment for uterine myomas, leiomyomas, or fibromas.
- Patients between the ages of 18-89.
- Patients that agree to participate and sign consent.
Who cannot join
- 1)Patients that decline to participate and/or are younger than 18 or older than 89.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Uterine Myomas, Leiomyomas, or Fibromas
- Keywords
- Myomas, Leiomyomas, Fibromas
- Medical subject headings
- Leiomyoma, Fibroma, Myoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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?
Measured: Baseline prior procedure, at follow up for 30 days (± 5 days), 6 months (±5 days) and 12 months (± 5 days) post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Policy approved describing all procedures as standard of care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Myomas, Leiomyomas, or FibromasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Sepulveda, Baptist Health South Florida
- Investigators
- Jaime Sepulveda, M.D, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362009
- Sponsor's protocol ID
- 13-099
- Status last verified
- Mar 2017
- First submitted
- 20 Jan 2015
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- South Miami Hospital Fibroid Registry
- ClinicalTrials.gov ID
- NCT02362009
- Acronym / sponsor ID
- 13-099
- Conditions
- Uterine Myomas, Leiomyomas, or Fibromas
- Keywords
- Myomas, Leiomyomas, Fibromas
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Policy approved describing all procedures as standard of care
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients seen for fibroid treatment services.
Key inclusion criteria (3 listed)
- Patients seeking treatment for uterine myomas, leiomyomas, or fibromas.
- Patients between the ages of 18-89.
- Patients that agree to participate and sign consent.
Key exclusion criteria (1 listed)
- 1)Patients that decline to participate and/or are younger than 18 or older than 89.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study was stopped early (reason given: Policy approved describing all procedures as standard of care). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
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Infertility, In Vitro Fertilization (IVF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Sepulveda, M.D principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Myomas, Leiomyomas, or Fibromas, run by Baptist Health South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Policy approved describing all procedures as standard of care). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.