Sonography Guided Transcervical Ablation of Uterine Fibroids

Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance

The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.

In this single-arm study, subjects who have symptomatic uterine fibroids will have transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using the Gynesonics Sonata System.

Inclusion Criteria:

• premenopausal
• ≥ 25 and ≤ 50 years of age at time of enrollment
• experienced heavy menstrual bleeding associated with fibroids (AUB-L) for at least 3 months
• between 1-10 fibroids of FIGO types 1, 2, 3, 4, and/or type 2-5, with diameter ≥ 1.0 cm and ≤ 5.0 cm
• at least one type 1, type 2, type 3, or type 2-5 fibroid.
• PBAC score ≥ 150 and ≤ 500
• consistent menstrual cycles
• not at material risk for pregnancy
• speaks and reads a language for which validated questionnaires are available
• willing and able to read, understand, and sign the informed consent form, to participate in the study and to adhere to all study follow-up requirements

Exclusion Criteria:

• pregnancy
• urgent need for surgery to treat fibroid symptoms
• desire for current or future childbearing
• presence of a tubal implant for sterilization
• postmenopausal by history
• presence of type 0 fibroids, unless < 1 cm in diameter
• presence of a single polyp ≥ 1.5 cm, or multiple polyps of any size
• any fibroid of FIGO type 1, type 2, type 3, type 4, or type 2-5 with diameter > 5.0 cm
• bulk symptoms in the presence of one or more fibroids of FIGO type 5, type 6, or type 7
• exclusive presence of fibroids that are insufficient to explain the severity of symptoms
• presence of clinically relevant fibroids that cannot be treated for technical reasons
• presence of an extrauterine pelvic mass that has not been diagnosed as benign
• IUD/IUS in situ within the washout period
• previous procedure for fibroids or heavy menstrual bleeding other than myomectomy
• myomectomy within 12 months
• any abnormality of the endometrial cavity that obstructs access of the handpiece
• contraindication to MRI
• total uterine volume > 1000 cc
• clinically significant adenomyosis
• confirmed or suspected diagnosis of clinically relevant endometriosis
• one or more clinically relevant fibroids that are significantly calcified.
• previous pelvic irradiation
• renal insufficiency [serum creatinine ≥ 1.5 mg/dL (132.6 μmol/L)]
• evidence of disorders of hemostasis (AUB-C)
• abnormal cervical cytology that is unevaluated or untreated in adherence with national guidelines
• endometrial hyperplasia (AUB-M), including simple hyperplasia without atypia
• confirmed abdominal / pelvic malignancy within the previous five years
• active pelvic infection or current positive testing for pelvic gonorrhea or chlamydia;
• use of a hormonally-relevant medication within the washout period
• use of an antifibrinolytic agent while undergoing any screening procedures
• current use of anticoagulant therapy
• chronic pelvic pain (disruptive for at least six months) or significant baseline pelvic or menstrual pain
• chronic uncontrolled moderate and severe hypertension
• hypoplastic or otherwise short uterus
• major medical or psychiatric illness or other factors that may affect general health or subject's ability to adhere to the follow-up schedule or provide valid subject self-assessment data
• any other reason for which the individual study subject is not appropriate or suitable for participation