The OPEN study

  • Research type

    Research Study

  • Full title

    Evaluation of uterine patency following sonography-guided transcervical ablation of fibroids

  • IRAS ID

    212454

  • Contact name

    Stephen Quinn

  • Contact email

    s.quinn@imperial.ac.uk

  • Sponsor organisation

    Gynesonics Inc

  • Clinicaltrials.gov Identifier

    NCT02844920

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    Uterine fibroids are the most common benign tumors in women found in approximately 20-25% in adult women. The lifetime risk of developing fibroids is as high as 70% in white women and greater than 80% in black women. Most fibroids do not cause symptoms, however, depending on the size and location of the tumors, fibroids can cause one or more of the following: heavy and painful periods, anaemia, pelvic/abdominal pressure, difficulties in passing urine, constipation, infertility, miscarriage and preterm labour. Fibroids impact the quality of life of millions of women and are associated with an increased utilisation of health care resources involving treatments that are often invasive and expensive.
    There are several treatment options for uterine fibroids. The Sonata System combines intrauterine ultrasound (IUUS) with radiofrequency (RF) ablation in a single handpiece, enabling transcervical visualisation and ablation of uterine fibroids without incisions. Sonata is intended to provide treatment of fibroids responsible for heavy menstrual bleeding (HMB). Surgical options for treatment of fibroids include hysterectomy and myomectomy, each of which can be performed via a number of approaches, such as an open incision, key-hole surgery, and hysteroscopy. These surgical procedures are associated with morbidity and mortality.
    One risk associated with some treatment options is adhesiogenesis, the formation of scar tissue. This scar tissue can close the cavity of the uterus and affect fertility which has been observed with other treatments for fibroids. Early reports from the 50-subject FAST-EU trial, a small observational study and commercial use of the Sonata System did not suggest adhesiogenesis after use of the Sonata device. This study is being undertaken to evaluate the rate of adhesion formation after the use of the Sonata system assessed by looking inside the uterus with a hysteroscope 6 weeks following the Sonata treatment.

  • REC name

    London - Hampstead Research Ethics Committee

  • REC reference

    17/LO/0052

  • Date of REC Opinion

    27 Feb 2017

  • REC opinion

    Further Information Favourable Opinion