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Patient Centered Results for Uterine Fibroids

NCT02260752 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3094

Last updated 2020-11-18

No results posted yet for this study

Summary

The overall goal of this project is to better enable patients with uterine fibroids (UF) to make informed decisions about treatment options by leveraging the highest possible evidence of healthcare quality. The foundation of this project will be a multi-site, prospective registry of a diverse group of women who have undergone either medical or surgical treatment for UF.

Specifically, the investigators are interested in: comparing management options for symptom relief; comparing management options for preserving reproductive function; and comparing effectiveness among different subpopulations, including consideration of patient needs and preferences of treatment options.

Conditions

  • Fibroids, Uterine

Interventions

PROCEDURE

hysterectomy

surgical removal of the uterus

PROCEDURE

Uterine arterial embolization

In uterine artery embolization, doctor uses a slender, flexible tube (catheter) to inject small particles (embolic agents) into the uterine arteries, which supply blood to your fibroids and uterus.the embolic agents are injected into these fibroid blood vessels. The goal is to block the fibroid vessels, starving the fibroids and causing them to shrink and die.

PROCEDURE

myomectomy

surgical procedure to remove uterine fibroids, but does not remove uterus

DRUG

Medical Therapy

treatment of uterine fibroids with only medications, no procedure or surgery is used

PROCEDURE

endometrial ablation

surgical procedure that destroys uterine lining via a telescope placed inside the uterus

PROCEDURE

magnetic resonance guided focused ultrasound

procedure that destroys fibroids while inside an MRI machine

PROCEDURE

radiofrequency ablation

procedure that uses heat to destroy uterine fibroids

Sponsors & Collaborators

Principal Investigators

  • Evan R Myers, MD · Duke University

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02260752 on ClinicalTrials.gov