Your session is about to expire
← Back to Search
Fibroid Treatments Comparison for Uterine Fibroids
N/A
Waitlist Available
Research Sponsored by Acessa Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are ≥ 18 years old and menstruating
Have symptomatic uterine fibroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Study Summary
This trial is comparing the costs of three different treatments for uterine fibroids and collecting data to satisfy the requirements of the FDA's 522 order.
Who is the study for?
This trial is for menstruating women over 18 with symptomatic uterine fibroids, who want to keep their uterus and have a uterine size ≤16 weeks. Participants should not be pregnant, have taken certain hormone treatments recently, or require other major surgeries. They must also agree to follow study procedures and provide informed consent.Check my eligibility
What is being tested?
The study compares the costs of three fibroid treatments: Global Fibroid Ablation (GFA), Myomectomy (surgical removal), and Uterine Artery Embolization (UAE). It's designed to fulfill FDA post-market requirements by monitoring these approaches in real-world settings.See study design
What are the potential side effects?
While specific side effects are not listed here, common risks may include pain at the treatment site, bleeding, infection risk from surgery or embolization procedures, possible damage to surrounding organs during treatment, and general anesthesia complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and still have my menstrual period.
Select...
I have symptoms from uterine fibroids.
Select...
All my fibroids are smaller than 10 cm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare direct cost of GFA compared to those of myomectomy and UAE
Compare rates of acute and near-term serious complications to the acute and near-term treatment-related serious adverse events of pivotal study.
Secondary outcome measures
Assess Uterine Fibroid Symptom Severity and Quality of Life (UFS-QoL) pre-treatment to post treatment in all treatment groups
Assess factors that influence indirect costs of the three treatment alternatives
Assess subject's satisfaction with her treatment
+4 moreTrial Design
2Treatment groups
Active Control
Group I: Ablation vs EmbolizationActive Control2 Interventions
Women are randomized 1:1 to either global fibroid ablation (GFA) or uterine artery embolization (UAE)
Group II: Ablation vs MyomectomyActive Control2 Interventions
Women are randomized 1:1 to either global fibroid ablation (GFA) or myomectomy (laparoscopic or abdominal)
Find a Location
Who is running the clinical trial?
Acessa Health, Inc.Lead Sponsor
4 Previous Clinical Trials
290 Total Patients Enrolled
David Eisenstein, MDStudy DirectorHenry Ford Hospital
1 Previous Clinical Trials
90 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My chronic pelvic pain is not caused by uterine fibroids.I have severe endometriosis or adenomyosis.I have used a depot GnRH agonist in the last 3 months.I have had or currently have pelvic inflammatory disease.I have had a gynecologic cancer or a condition that could turn into cancer in the last 5 years.I have fibroids within the wall of my uterus that are best removed through a scope.I am not open to being randomly assigned to a treatment.I am at high risk for or have severe scar tissue inside my abdomen.I need a major surgery soon, like fixing a hernia.I am 18 or older and still have my menstrual period.I have symptoms from uterine fibroids.All my fibroids are smaller than 10 cm.I want to keep my uterus.I can understand and agree to the study's details.I have received radiation therapy in the pelvic area.I have a pelvic mass larger than 3 cm not in my uterus.I have a fibroid in my cervix.I cannot have laparoscopic surgery or be put under general anesthesia due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Ablation vs Embolization
- Group 2: Ablation vs Myomectomy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goals is this trial seeking to accomplish?
"The principal metric of this 30 day trial will be a comparison between the direct costs associated with GFA, myomectomy, and UAE. Secondary goals include assessing menstrual bleeding using the Menorrhagia Impact Questionnaire (MIQ), tracking post-discharge procedure related complications and reinterventions for all three treatments, as well as gauging patient satisfaction through an Overall Treatment Effect questionnaire at 12 months post-procedure."
Answered by AI
Is this research currently enrolling participants?
"Based on the information provided by clinicaltrials.gov, this trial is no longer actively enrolling patients. The study was posted back in June of 2014 and last updated in April 2022; however, there are currently 47 other trials searching for participants."
Answered by AI
What locations are participating in the clinical trial?
"Patients are being enrolled at University of California, Los Angeles (Santa Monica), Georgia's Augusta University, Illinois' University of Chicago Medicine and Biological Sciences, Massachusetts', as well as 9 other sites."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger