ULTRA (Uterine Leiomyoma Treatment with Radiofrequency Ablation)

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Presentation transcript:

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

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

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

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

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

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