Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
NCT02100904 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Radiofrequency ablation of fibroids
- PROCEDURE Myomectomy of fibroids
Study Locations (12)
Texas
- Tassone Advanced Gynecology — Austin
- UT Southwestern — Dallas
- MacArthur Medical Center — Irving
- Acacia OBGYN — San Antonio
California
- UC Irvine Medical Center — Irvine
- University of California, San Diego — San Diego
- University of California, San Francisco — San Francisco
Illinois
- Gynecology Institute of Chicago — Chicago
- Women's Healthcare Associates of IL, SC — Homewood
Delaware
- Dedicated to Women — Dover
Georgia
- Fibroid and Pelvic Wellness Center of Georgia — Alpharetta
North Carolina
- Duke University — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 578 participants |
| Start Date | 2014-05 |
| Est. Completion | 2026-04-01 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02100904
The ClinicalTrials.gov registry entry for NCT02100904 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 578 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francis, which has 1,574 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Uterine Fibroids appearing as the primary indexed condition, and to 2 interventions — of which Radiofrequency ablation of fibroids is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02100904 reports 12 study locations spanning 6 distinct geographic areas — top geographies include Texas, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02100904 about?
NCT02100904 is a clinical study titled "Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry". 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 laparosc...
What is the current status of trial NCT02100904?
This trial is currently active not recruiting. The enrollment target is 578 participants. The study started on 2014-05. Estimated completion is 2026-04-01.
What conditions does trial NCT02100904 study?
This clinical trial studies the following conditions: Uterine Fibroids. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02100904?
The interventions under investigation include: Radiofrequency ablation of fibroids (PROCEDURE), Myomectomy of fibroids (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02100904?
This trial is sponsored by University of California, San Francis, which has 1,574 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02100904 being conducted?
This trial has 12 study locations across California, Delaware, Georgia, Illinois, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.