Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids
NCT ID: NCT02819609
Last Updated: 2016-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
12234 participants
OBSERVATIONAL
2014-11-30
2015-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Myomectomy
Women with uterine fibroids who underwent myomectomy as their index procedure as part of their routine clinical care
myomectomy
Myomectomy as part of routine clinical care
Endometrial ablation
Women with uterine fibroids who underwent endometrial ablation as their index procedure as part of their routine clinical care
endometrial ablation
Endometrial ablation as part of routine clinical care
Uterine artery embolization
Women with uterine fibroids who underwent uterine artery embolization as their index procedure as part of their routine clinical care
uterine artery embolization
Uterine artery embolization as part of routine clinical care
MRI-guided focused ultrasound ablation
Women with uterine fibroids who underwent MRI-guided focused ultrasound ablation as their index procedure as part of their routine clinical care
MRI-guided focused ultrasound ablation
MRI-guided focused ultrasound ablation as part of routine clinical care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
myomectomy
Myomectomy as part of routine clinical care
endometrial ablation
Endometrial ablation as part of routine clinical care
uterine artery embolization
Uterine artery embolization as part of routine clinical care
MRI-guided focused ultrasound ablation
MRI-guided focused ultrasound ablation as part of routine clinical care
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least 1 of the procedures of interest occurring between January 1, 2005 - December 31, 2011
* ≥ 18 years and \< 55 years of age at the index date
Exclusion Criteria
* First recorded diagnosis of uterine fibroids occurring beyond four weeks after the Index Date ONLY for patients who underwent endometrial ablation or hysterectomy
* Patients with a record of any procedures of interest occurring before January 1, 2005
18 Years
54 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Center for Medical Technology Policy
UNKNOWN
Duke University
OTHER
Quintiles, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Priscilla Velentgas
Senior Director of Epidemiology and Health Outcomes
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CE-12-11-4430
Identifier Type: -
Identifier Source: org_study_id