Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry (ULTRA Registry)

April 23, 2026 updated by: University of California, San Francisco

The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF ablation (Acessa).

The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone laparoscopic RF ablation (Acessa) or myomectomy within the United States. Participants will be recruited through study materials distributed at clinical offices across the country where gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will consent to participate in a 3 year prospective study conducted by UCSF but the fibroid procedure will be performed by the study participants' own gynecologist. We will evaluate changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18, 24, 30, and 36 months after RFA (Acessa). We will determine long-term efficacy of RFA (Acessa) by evaluating the rate of re-treatment for symptomatic fibroids after the RFA (Acessa) procedure versus myomectomy. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes.

UC San Francisco will have oversight of all scientific and administrative aspects of the study. All study data will be stored securely in a HIPAA compliant, secure database monitored by the UC San Francisco Coordinating Center.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

578

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92868
        • UC Irvine Medical Center
      • San Diego, California, United States, 92037
        • University of California, San Diego
      • San Francisco, California, United States, 94115
        • University of California, San Francisco
    • Delaware
      • Dover, Delaware, United States, 19904
        • Dedicated to Women
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Fibroid and Pelvic Wellness Center of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60605
        • Gynecology Institute of Chicago
      • Homewood, Illinois, United States, 60430
        • Women's Healthcare Associates of IL, SC
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Duke University
    • Texas
      • Austin, Texas, United States, 78723
        • Tassone Advanced Gynecology
      • Dallas, Texas, United States, 75390
        • UT Southwestern
      • Irving, Texas, United States, 75062
        • MacArthur Medical Center
      • San Antonio, Texas, United States, 78217
        • Acacia OBGYN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women with uterine fibroids who are planning to undergo or have undergone radiofrequency ablation (Acessa) or myomectomy treatment.

Description

Inclusion Criteria:

  • Planning to undergo or have undergone* RF ablation (Acessa) or myomectomy (laparoscopic or abdominal) for treatment of uterine fibroids.
  • Able to give informed consent

  • Speak English or Spanish

    • Women enrolled at contracted clinical sites must enroll prior to their RF ablation treatment

Exclusion Criteria:

  • <21 years of age
  • Plan to undergo hysteroscopic myomectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women undergoing radiofrequency ablation.
Most women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa).
Procedure: Radiofrequency ablation of fibroids
Women undergoing myomectomy
About 25% of women in the trial will be in the group who receive treatment with myomectomy.
Procedure: Myomectomy of fibroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in fibroid-related symptoms after the RFA or myomectomy procedure.
Time Frame: Baseline to 3 years
We will use standard questionnaires for women with fibroids to assess changes in fibroid symptoms including menstrual pattern and flow and overall quality of life.
Baseline to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure.
Time Frame: Baseline to 6 weeks
Baseline to 6 weeks
Operative complications
Time Frame: Baseline to 6 weeks
Operative complications are rare but may include excessive blood loss, uterine or pelvic infection, injury to organs adjacent to uterus such as bowel or bladder.
Baseline to 6 weeks
Pregnancy rate after the RFA or myomectomy procedure.
Time Frame: Baseline to 3 years
Baseline to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Vanessa Jacoby, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimated)

April 1, 2014

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-13325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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