Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
NCT ID: NCT02100904
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
578 participants
OBSERVATIONAL
2014-05-31
2026-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Women undergoing radiofrequency ablation.
Most women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa).
Radiofrequency ablation of fibroids
Women undergoing myomectomy
About 25% of women in the trial will be in the group who receive treatment with myomectomy.
Myomectomy of fibroids
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Radiofrequency ablation of fibroids
Myomectomy of fibroids
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Plan to undergo hysteroscopic myomectomy
21 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vanessa Jacoby, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UC Irvine Medical Center
Irvine, California, United States
University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Dedicated to Women
Dover, Delaware, United States
Fibroid and Pelvic Wellness Center of Georgia
Alpharetta, Georgia, United States
Gynecology Institute of Chicago
Chicago, Illinois, United States
Women's Healthcare Associates of IL, SC
Homewood, Illinois, United States
Duke University
Durham, North Carolina, United States
Tassone Advanced Gynecology
Austin, Texas, United States
UT Southwestern
Dallas, Texas, United States
MacArthur Medical Center
Irving, Texas, United States
Acacia OBGYN
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rubio EM, Hilton JF, Bent S, Parvataneni R, Oberman E, Saberi NS, Varon S, Schembri M, Waetjen LE, Jacoby VL. Complementary and Alternative Medicine Use Among Women with Symptomatic Uterine Fibroids. J Womens Health (Larchmt). 2023 May;32(5):546-552. doi: 10.1089/jwh.2022.0094. Epub 2023 Apr 6.
Related Links
Access external resources that provide additional context or updates about the study.
Fibroid Trials at UCSF
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14-13325
Identifier Type: -
Identifier Source: org_study_id