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
Sponsor organisation
Gynesonics Inc
Clinicaltrials.gov Identifier
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