Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
ULTRA Registry
1 other identifier
observational
578
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2014
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2014
CompletedFirst Posted
Study publicly available on registry
April 1, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
April 27, 2026
April 1, 2026
12.2 years
March 27, 2014
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in fibroid-related symptoms after the RFA or myomectomy procedure.
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 Outcomes (3)
Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure.
Baseline to 6 weeks
Operative complications
Baseline to 6 weeks
Pregnancy rate after the RFA or myomectomy procedure.
Baseline to 3 years
Study Arms (2)
Women undergoing radiofrequency ablation.
Most women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa).
Women undergoing myomectomy
About 25% of women in the trial will be in the group who receive treatment with myomectomy.
Interventions
Eligibility Criteria
Women with uterine fibroids who are planning to undergo or have undergone radiofrequency ablation (Acessa) or myomectomy treatment.
You may qualify if:
- 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
You may not qualify if:
- \<21 years of age
- Plan to undergo hysteroscopic myomectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
UC Irvine Medical Center
Irvine, California, 92868, United States
University of California, San Diego
San Diego, California, 92037, United States
University of California, San Francisco
San Francisco, California, 94115, United States
Dedicated to Women
Dover, Delaware, 19904, United States
Fibroid and Pelvic Wellness Center of Georgia
Alpharetta, Georgia, 30005, United States
Gynecology Institute of Chicago
Chicago, Illinois, 60605, United States
Women's Healthcare Associates of IL, SC
Homewood, Illinois, 60430, United States
Duke University
Durham, North Carolina, 27704, United States
Tassone Advanced Gynecology
Austin, Texas, 78723, United States
UT Southwestern
Dallas, Texas, 75390, United States
MacArthur Medical Center
Irving, Texas, 75062, United States
Acacia OBGYN
San Antonio, Texas, 78217, United States
Related Publications (1)
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.
PMID: 37023398DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vanessa Jacoby, MD
University of California, San Francisco
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2014
First Posted
April 1, 2014
Study Start
May 1, 2014
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share