Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry (NCT02100904)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UC Irvine Medical Center — Irvine, California
Age range: 21 Years
🧪 Interventions in This Study
- Radiofrequency ablation of fibroids (PROCEDURE)
- Myomectomy of fibroids (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- UC Irvine Medical Center — Irvine, California
- University of California, San Diego — San Diego, California
- University of California, San Francisco — San Francisco, California
- Dedicated to Women — Dover, Delaware
- Fibroid and Pelvic Wellness Center of Georgia — Alpharetta, Georgia
- Gynecology Institute of Chicago — Chicago, Illinois
- Women's Healthcare Associates of IL, SC — Homewood, Illinois
- Duke University — Durham, North Carolina
- Tassone Advanced Gynecology — Austin, Texas
- UT Southwestern — Dallas, Texas
- MacArthur Medical Center — Irving, Texas
- Acacia OBGYN — San Antonio, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.