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Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry (ULTRA Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02100904
Recruitment Status : Recruiting
First Posted : April 1, 2014
Last Update Posted : December 20, 2019
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment
Uterine Fibroids Procedure: Radiofrequency ablation of fibroids Procedure: Myomectomy of fibroids

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
Study Start Date : May 2014
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids

Group/Cohort Intervention/treatment
Women undergoing radiofrequency ablation.
Most women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa).
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.
Procedure: Myomectomy of fibroids

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure. [ Time Frame: Baseline to 6 weeks ]
  2. Operative complications [ Time Frame: Baseline to 6 weeks ]
    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.

  3. Pregnancy rate after the RFA or myomectomy procedure. [ Time Frame: Baseline to 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with uterine fibroids who are planning to undergo or have undergone radiofrequency ablation (Acessa) or myomectomy treatment.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • <21 years of age
  • Plan to undergo hysteroscopic myomectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02100904

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Contact: Vanessa Monzon 510-999-4326
Contact: Ruth Gebrezghi 510-999-4326

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United States, California
University of California, San Diego Not yet recruiting
San Diego, California, United States, 92037
Contact: Deyna Arrellano    858-822-2916      
Principal Investigator: Shira Varon, MD         
University of California, San Francisco Active, not recruiting
San Francisco, California, United States, 94115
United States, Delaware
Dedicated to Women Recruiting
Dover, Delaware, United States, 19904
Contact: Melanie Kline    302-674-0223      
Principal Investigator: Robert Hartmann, MD         
United States, Georgia
Fibroid and Pelvic Wellness Center of Georgia Recruiting
Alpharetta, Georgia, United States, 30005
Contact: Patricia Compres    770-475-4499      
Contact: Jessica Sanders    (770) 475-4499      
Principal Investigator: Soyini Hawkins, MD         
United States, Illinois
Gynecology Institute of Chicago Recruiting
Chicago, Illinois, United States, 60605
Contact: Sarah Halfmann    312-929-9191      
Principal Investigator: Nicole Williams, MD         
Women's Healthcare Associates of IL, SC Recruiting
Homewood, Illinois, United States, 60430
Contact: Devra Gills         
Principal Investigator: Biren Shah, MD         
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27704
Contact: Bonnie Thiele         
Principal Investigator: Craig Sobolewski, MD         
United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Giselle Huet         
Contact    214-648-9464      
Principal Investigator: Kimberly A Kho, MD         
MacArthur Medical Center Recruiting
Irving, Texas, United States, 75062
Contact: Jai Fields         
Principal Investigator: Brian Enggano, MD         
Acacia OBGYN Recruiting
San Antonio, Texas, United States, 78217
Contact: Rachel Guillen    210-852-6788      
Principal Investigator: Henry Garza, MD         
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Vanessa Jacoby, MD University of California, San Francisco
Additional Information:
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Responsible Party: University of California, San Francisco Identifier: NCT02100904    
Other Study ID Numbers: 14-13325
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Keywords provided by University of California, San Francisco:
Radiofrequency ablation
Additional relevant MeSH terms:
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Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases