1. ULTRA (Uterine Leiomyoma Treatment with Radiofrequency Ablation)
Vanessa Jacoby, MD, MAS
Associate Professor
Obstetrics, Gynecology, and Reproductive Sciences
University of California, San Francisco

2. ULTRA (Uterine Leiomyoma Treatment with Radiofrequency Ablation)
AcessaTM is most recent FDA approved device to treat fibroids (November 2012)
AcessaTM system enables laparoscopic radiofrequency ablation (RFA) of fibroids

3. ULTRA (Uterine Leiomyoma Treatment with Radiofrequency Ablation)
Post-market observational cohort study to assess safety and effectiveness of women undergoing Acessa treatment
Investigator-initiated,
PI Dr. Vanessa Jacoby, UCSF
Funded by Acessa Health under independent UCSF contract with no scientific input or data access by industry
fibroids.ucsf.edu

4. ULTRA (Uterine Leiomyoma Treatment with Radiofrequency Ablation)
Women enrolled in real-world practice settings across the country (primarily private practice)
Recruitment:
Phase 1: Voluntary referrals from clinicians (25 sites)
Phase 2: “Engaged” clinical sites, standard multi-center study
Study sites recruit and enroll: baseline visit prior to Acessa
UCSF Coordinating Center does follow-up for 3 years after surgery
Online consent and questionnaires (English and Spanish), sent via text message or

5. ULTRA (Uterine Leiomyoma Treatment with Radiofrequency Ablation)
Outcomes:
Operative morbidity
Change in fibroid symptoms (validated questionnaires)
Treatment failure (need for fibroid surgery/procedure)
Pregnancy outcomes
Queried every 6 months with questionnaires (patient-reported outcomes)
Medical records obtained at follow-up for repeat imaging

6. ULTRA (Uterine Leiomyoma Treatment with Radiofrequency Ablation)
Collaborations
Outcome assessment (CRFs and questionnaires) harmonized with COMPARE-UF
NIH R01 submission Oct 2018 to include COMPARE-UF and ULTRA
CRN: Opportunity to pilot new data elements in ongoing post-market device study