Uterine FibroidsULTRA RegistryNCT02100904
Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
An observational study of Uterine Fibroids, run by University of California, San Francisco at 12 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- Radiofrequency ablation of fibroids and Myomectomy of fibroids
- Type of treatment
- Surgery or procedure
- How many people
- 578 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2014to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with uterine fibroids who are planning to undergo or have undergone radiofrequency ablation (Acessa) or myomectomy treatment.
Who may be able to join
- 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
Who cannot join
- <21 years of age
- Plan to undergo hysteroscopic myomectomy
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Fibroid and Pelvic Wellness Center of Georgia
Alpharetta, Georgia, 30005
Tassone Advanced Gynecology
Austin, Texas, 78723
Gynecology Institute of Chicago
Chicago, Illinois, 60605
UT Southwestern
Dallas, Texas, 75390
Dedicated to Women
Dover, Delaware, 19904
Duke University
Durham, North Carolina, 27704
Women's Healthcare Associates of IL, SC
Homewood, Illinois, 60430
UC Irvine Medical Center
Irvine, California, 92868
MacArthur Medical Center
Irving, Texas, 75062
Acacia OBGYN
San Antonio, Texas, 78217
University of California, San Diego
San Diego, California, 92037
University of California, San Francisco
San Francisco, California, 94115
About this study
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
- Uterine Fibroids
- Being tested
- Radiofrequency ablation of fibroids, Myomectomy of fibroids
- Keywords
- Fibroids, Radiofrequency ablation, Myomectomy
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation of fibroidsProcedure or surgery
Myomectomy of fibroidsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing radiofrequency ablation. | Most women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa). Receives: Procedure: Radiofrequency ablation of fibroids | |
| Women undergoing myomectomy | About 25% of women in the trial will be in the group who receive treatment with myomectomy. Receives: Procedure: Myomectomy of fibroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 years
Secondary outcomes (3)
Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure.
Measured: Baseline to 6 weeks
Operative complications
Operative complications are rare but may include excessive blood loss, uterine or pelvic infection, injury to organs adjacent to uterus such as bowel or bladder.
Measured: Baseline to 6 weeks
Pregnancy rate after the RFA or myomectomy procedure.
Measured: Baseline to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startMay 2014
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Jacoby, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100904
- Sponsor's protocol ID
- 14-13325
- Acronym
- ULTRA Registry
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2014
- Last updated
- 27 Apr 2026
- Results posted
- No
- Individual data sharing
- No
Publications
Brito KS, Schembri M, Parvataneni R, Varon S, Salamat-Saberi N, Sobolewski CJ, Hawkins S, Williams N, Tassone S, Allen A, Jacoby VL, Waetjen LE. Treatment Failure After Laparoscopic Radiofrequency Ablation Compared With Myomectomy. Obstet Gynecol. 2026 Oct 13. doi: 10.1097/AOG.0000000000006444. Online ahead of print.
PubMed 42868327Rubio 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.
PubMed 37023398
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
- ClinicalTrials.gov ID
- NCT02100904
- Acronym / sponsor ID
- ULTRA Registry / 14-13325
- Conditions
- Uterine Fibroids
- Keywords
- Fibroids, Radiofrequency ablation, Myomectomy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 578 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women undergoing radiofrequency ablation. | – | Procedure: Radiofrequency ablation of fibroidsMost women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa). |
| Women undergoing myomectomy | – | Procedure: Myomectomy of fibroidsAbout 25% of women in the trial will be in the group who receive treatment with myomectomy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with uterine fibroids who are planning to undergo or have undergone radiofrequency ablation (Acessa) or myomectomy treatment.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- <21 years of age
- Plan to undergo hysteroscopic myomectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation of fibroids | Procedure or surgery | Women undergoing radiofrequency ablation. |
| Myomectomy of fibroids | Procedure or surgery | Women undergoing myomectomy |
Primary outcome
Changes in fibroid-related symptoms after the RFA or myomectomy procedure.
Time frame: Baseline to 3 years
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.
3 secondary outcomes
Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure.
Time frame: Baseline to 6 weeks
Operative complications
Time frame: Baseline to 6 weeks
Pregnancy rate after the RFA or myomectomy procedure.
Time frame: Baseline to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 42868327Brito KS, Schembri M, Parvataneni R, Varon S, Salamat-Saberi N, Sobolewski CJ, Hawkins S, Williams N, Tassone S, Allen A, Jacoby VL, Waetjen LE. Treatment Failure After Laparoscopic Radiofrequency Ablation Compared With Myomectomy. Obstet Gynecol. 2026 Oct 13. doi: 10.1097/AOG.0000000000006444. Online ahead of print.
- Derived from this study: PubMed 37023398Rubio 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.
- Fibroid Trials at UCSFLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Jacoby, MD principal investigator
University of California, San Francisco
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroids, run by University of California, San Francisco at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fibroid-related symptoms after the RFA or myomectomy procedure. (time frame: Baseline to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02100904, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.