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ULTRA ( U terine L eiomyoma T reatment with R adiofrequency A blation)

ULTRA is a post-market observational cohort study assessing the safety and effectiveness of AcessaTM, a laparoscopic radiofrequency ablation system for treating fibroids. The study is conducted by Dr. Vanessa Jacoby at UCSF and funded by Acessa Health. Women from various real-world practice settings across the country are enrolled in the study, with outcomes measured through questionnaires and medical records.

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ULTRA ( U terine L eiomyoma T reatment with R adiofrequency A blation)

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

  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 Acessatreatment • 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 email

  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

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