Pressure-Induced Fibroid Ischemia: First-In-Human Experience with a Novel Device for Laparoscopic Treatment of Symptomatic Uterine Fibroids.

ABSTRACT: The purpose of this study was to assess the feasibility of use of a novel uterine fibroid treatment device hypothesized to cause fibroid infarction by increasing intra-tumoral pressure. Between August 2019 and January 2020, 21 uterine fibroids were treated in 16 symptomatic pre-menopausal black women. Pelvic magnetic resonance imaging was performed before the procedure, a day after the procedure and at 1, 3, 6, and 12 months. The subjects were also followed for clinical outcomes and quality of life up to 12 months at a single investigational site. At 3 months, the mean reduction in the fibroid volume was 36.3% (P = .002). Incremental reduction in volume peaked at the end of the follow-up, at the 12-month mark (60.4%; P = .008). There were no procedures in which the users failed to perform

SUBMITTER: Tal MG 

PROVIDER: S-EPMC9360636 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature