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.|
|ClinicalTrials.gov Identifier: NCT02100904|
Recruitment Status : Recruiting
First Posted : April 1, 2014
Last Update Posted : April 4, 2018
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) 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 laparoscopic RF ablation (Acessa) surgery 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. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes. The gynecologists performing the laparoscopic RF ablation (Acessa) surgery will be asked to consent to complete a brief study questionnaire with information on demographics, work history, professional training, and practice setting.
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|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Women undergoing radiofrequency ablation.
All women in the trial will be in this group who receive treatment with radiofrequency ablation (Acessa).
|Procedure: Radiofrequency ablation of fibroids|
- Changes in fibroid-related symptoms after the Acessa 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.
- Rate of re-intervention for recurrent fibroid symptoms following the Acessa procedure. [ Time Frame: Baseline to 6 weeks ]
- 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.
- Pregnancy rate after the Acessa procedure. [ Time Frame: Baseline to 3 years ]
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 ClinicalTrials.gov identifier (NCT number): NCT02100904
|Contact: Vanessa Monzonfirstname.lastname@example.org|
|Contact: Ruth Gebrezghiemail@example.com|
|United States, California|
|University of California, San Francisco||Active, not recruiting|
|San Francisco, California, United States, 94115|
|United States, Illinois|
|Gynecology Institute of Chicago||Recruiting|
|Chicago, Illinois, United States, 60605|
|Contact: Sarah Halfmann 312-929-9191|
|Principal Investigator: Nicole Williams, MD|
|United States, Texas|
|UT Southwestern||Not yet recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Kimberly Kho, MD|
|Principal Investigator: Kimberly A Kho, MD|
|MacArthur Medical Center||Recruiting|
|Irving, Texas, United States, 75062|
|Contact: Jai Fields|
|Principal Investigator: Brian Enggano, MD|
|Principal Investigator:||Vanessa Jacoby, MD||University of California, San Francisco|