Which fibroid treatment is cheapest and safest? new study compares options

NCT ID NCT02163525

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

114 people

The number who actually took part.

Start date

Jun 2014

Finished

Sep 2025

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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

  • Aspen Surgery Center/John Muir Hospital

    Walnut Creek, California, 94598, United States

  • Augusta University

    Augusta, Georgia, 30912-3360, United States

  • Brigham and Women's Hospital

    Jamaica Plain, Massachusetts, 02130, United States

  • Henry Ford Hospital

    West Bloomfield, Michigan, 48322, United States

  • INOVA

    Falls Church, Virginia, 60637, United States

  • Texas Fertility Center

    Austin, Texas, 78731, United States

  • University of California, Los Angeles

    Santa Monica, California, 90401, United States

  • University of Chicago Medicine and Biological Sciences

    Chicago, Illinois, 60637, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States