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NCT02100904 · ClinicalTrials.gov registry record
Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
A clinical trial of Uterine Fibroids, sponsored by University of California, San Francisco.
- Active
- Registry status
- 578
- Enrollment target
- 12
- Study locations
NCT02100904: Active study of Uterine Fibroids, sponsored by University of California, San Francisco.
NCT02100904 is a study of Uterine Fibroids that is active but no longer recruiting, run by University of California, San Francisco. The registered enrollment target is 578 participants, above the 186-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (211% higher). The trial reports 12 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02100904, a study of Uterine Fibroids, is active but no longer recruiting, sponsored by University of California, San Francisco.
- ACTIVE NOT RECRUITING
- Registry status
- 578 participants
- Enrollment target
- 12
- Study locations
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.
Primary Outcome
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.
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 |
What the registry record for NCT02100904 still lists
NCT02100904 is an observational study that tracks outcomes without assigning an intervention. The registered 578 participants enrollment target is mid-sized for trials with a published cap, above the 186-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (211% higher).
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.
NCT02100904 lists 12 locations in 6 states (Texas, California, Illinois).
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.
What interventions are being tested in trial NCT02100904?
The interventions under investigation include: Radiofrequency ablation of fibroids (PROCEDURE), Myomectomy of fibroids (PROCEDURE).
Who is sponsoring clinical trial NCT02100904?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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
Similar trials for Uterine Fibroids
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02100904's enrollment target sits among peer trials
578 2nd of 10 the highest of 10 other Uterine Fibroids trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Uterine Fibroids trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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