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
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.