Health Problem: Uterine fibroids (UF) are benign tumors of the myometrium, the smooth muscle layer of the uterus. Approximately 25% of fibroids are symptomatic. Fibroids are the most common indication for hysterectomy and may be associated with infertility and adverse pregnancy outcomes.

Technology Description: The Acessa System is a minimally invasive, uterine-sparing, ultrasound-guided system for performing laparoscopic radiofrequency volumetric thermal ablation (RFVTA) of UF in the outpatient setting. Multiple fibroids may be treated through a single uterine puncture. In addition to radiofrequency energy for ablation, the generator also performs traditional electrocautery for control of bleeding. No suturing or uterine incisions are required.

Controversy: The efficacy and safety of RFVTA compared with other clinical alternatives, particularly other uterine-sparing technologies such as magnetic resonance guided focused ultrasound and uterine artery embolization, are unresolved. There is a lack of comparative evidence evaluating the safety and efficacy of RFVTA compared with other minimally invasive procedures or surgical procedures among women who wish to reduce symptoms related to UF yet still have the desire to maintain fertility.

Key Questions:

  • Is RFVTA with the Acessa System effective for treating UF?

  • How does RFVTA with the Acessa System compare with alternative procedures for treatment of symptomatic UF?

  • Is RFVTA with the Acessa System safe?

  • Have definitive patient selection criteria been identified for RFVTA with the Acessa System for the treatment of symptomatic UF?

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