Which fibroid treatment is cheapest and safest? new study compares options
NCT ID NCT02163525
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study looked at 114 women with symptomatic uterine fibroids who wanted to keep their uterus. It compared the costs and short-term safety of three procedures: radiofrequency ablation (Acessa), myomectomy (surgical removal of fibroids), and uterine artery embolization (blocking blood flow to fibroids). The goal was to see which approach is most cost-effective and has the fewest complications soon after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiofrequency ablation (Acessa procedure), myomectomy, or uterine artery embolization
- What this could lead to
- If successful, this study could help doctors and patients choose the most cost-effective and safe treatment option for uterine fibroids while preserving the uterus.
- What could go wrong
- This is a completed observational study comparing existing procedures, not testing a new breakthrough. Results may not apply to all patients, and individual outcomes vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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114 people
The number who actually took part.
- Start date
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Jun 2014
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Are ≥ 18 years old and menstruating * Have symptomatic uterine fibroids * Have a uterine size ≤ 16 gestational weeks as determined by pelvic exam * Have all fibroids that are less than 10 cm in any diameter * Desire uterine conservation * Have had a normal Pap smear within the past 36 months defined as "no untreated cervical malignancy or dysplasia." * Are willing and able to comply with all study tests, procedures, and assessment tools * Are capable of providing informed consent. Exclusion Criteria: * Have contraindications for laparoscopic surgery and/or general anesthesia. * Are expected to be high risk for, or are known to have, significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus) * Patients requiring major elective concomitant procedures (e.g., hernia repair) * Are pregnant or lactating * Have taken any depot gonadotropin releasing hormone (GnRh) agonist within three months prior to the screening procedures * Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed at least 10 days prior to treatment * Have chronic pelvic pain known to not be due to uterine fibroids * Have known or suspected endometriosis Stage 3 or 4, adenomyosis * Have active or history of pelvic inflammatory disease * Have a history of, or evidence of, gynecologic malignancy or pre-malignancy within the past five years * Have had pelvic radiation * Have a non-uterine pelvic mass over 3 cm * Have a cervical myoma * Have one or more completely intracavitary submucous fibroids (Type 0) or only Type 0/1 submucous fibroids that are better treated via hysteroscopic methods * In the medical judgment of the investigator should not participate in the study * Are not willing to be randomized to treatment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aspen Surgery Center/John Muir Hospital
Walnut Creek, California, 94598, United States
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Augusta University
Augusta, Georgia, 30912-3360, United States
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Brigham and Women's Hospital
Jamaica Plain, Massachusetts, 02130, United States
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Henry Ford Hospital
West Bloomfield, Michigan, 48322, United States
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INOVA
Falls Church, Virginia, 60637, United States
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Texas Fertility Center
Austin, Texas, 78731, United States
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University of California, Los Angeles
Santa Monica, California, 90401, United States
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University of Chicago Medicine and Biological Sciences
Chicago, Illinois, 60637, United States
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University of Rochester Medical Center
Rochester, New York, 14642, United States