Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
Public ClinicalTrials.gov record NCT02100904. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02100904
- Recruitment status
- Active, not recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 578 participants
Conditions and interventions
Conditions
Interventions
- Radiofrequency ablation of fibroids Procedure
- Myomectomy of fibroids Procedure
Procedure
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2014 (Type not available)
- Primary completion
- Jun 30, 2026 (Estimated)
- Completion
- Jun 30, 2026 (Estimated)
- Last update posted
- Apr 27, 2026
2014 – 2026
United States locations
- U.S. sites
- 12
- U.S. states
- 6
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC Irvine Medical Center | Irvine | California | 92868 | — |
| University of California, San Diego | San Diego | California | 92037 | — |
| University of California, San Francisco | San Francisco | California | 94115 | — |
| Dedicated to Women | Dover | Delaware | 19904 | — |
| Fibroid and Pelvic Wellness Center of Georgia | Alpharetta | Georgia | 30005 | — |
| Gynecology Institute of Chicago | Chicago | Illinois | 60605 | — |
| Women's Healthcare Associates of IL, SC | Homewood | Illinois | 60430 | — |
| Duke University | Durham | North Carolina | 27704 | — |
| Tassone Advanced Gynecology | Austin | Texas | 78723 | — |
| UT Southwestern | Dallas | Texas | 75390 | — |
| MacArthur Medical Center | Irving | Texas | 75062 | — |
| Acacia OBGYN | San Antonio | Texas | 78217 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02100904, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 27, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02100904 live on ClinicalTrials.gov.