The INTEGRITY Trial: Preservation of Uterine-Wall Integrity 12 Months After Transcervical Fibroid Ablation with the Sonata System

Marlies Bongers*, Janesh Gupta, Jose Gerardo Garza-Leal, Matthew Brown, Ricardo Felberbaum

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Web of Science)

Abstract

Objective: The aim of this research was to evaluate uterine-wall integrity 12 months after transcervical fibroid ablation (TFA) of uterine fibroids with the Sonata (R) system (Gynesonics Inc., Redwood City, CA). Materials and Methods: INTEGRITY is a secondary analysis of the FAST-EU clinical trial, a prospective, longitudinal, multicenter single-armed trial involving women with heavy menstrual bleeding secondary to fibroids who were treated at 7 academic and community hospitals in the United Kingdom, the Netherlands, and Mexico with transcervical, intrauterine, ultrasound-guided radiofrequency ablation (the Sonata system). TFA was performed on up to 5 fibroids per subject ranging from 1-5 cm in diameter as determined by magnetic resonance imaging (MRI). All measurements and comparisons, including uterine-wall thicknesses were derived from baseline and 12-month MRI scans by an independent core MRI center. Scans were analyzed to assess preservation of uterine-wall integrity and reviewed for uterine-wall anomalies after TFA with the Sonata system. Results: Twenty-nine patients had baseline and 12-month MRI with contrast enhancement. Minimum uterine-wall thicknesses in all visible slices were >2.5 mm in diameter. No areas on MRI indicated any loss of uterine-wall integrity, compared with baseline imaging; comparison of baseline and postablation uterine-wall thicknesses revealed no significant changes. Conclusion: Transcervical fibroid ablation with the Sonata system was associated with preservation of uterine-wall integrity in this patient cohort.
Original languageEnglish
Pages (from-to)299-303
Number of pages5
JournalJournal of Gynecologic Surgery
Volume35
Issue number5
Early online date19 Aug 2019
DOIs
Publication statusPublished - 1 Oct 2019

Keywords

  • uterine fibroids
  • radiofrequency ablation
  • transcervical fibroid ablation (TFA)
  • uterine preserving
  • PREVIOUS CESAREAN-SECTION
  • GUIDED RADIOFREQUENCY ABLATION
  • FOCUSED ULTRASOUND SURGERY
  • SEGMENT THICKNESS
  • PREGNANCY OUTCOMES
  • ULTRASONOGRAPHIC EVALUATION
  • SONOGRAPHIC MEASUREMENT
  • THERMAL ABLATION
  • LIVE BIRTH
  • RUPTURE

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