sonography guided transcervical ablation of uterine fibroids

Conditions: Menorrhagia

Summary: 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.

Eligibility criteria:
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

Keywords: abnormal uterine bleeding associated with fibroids aub-l fibroids heavy menstrual bleeding hmb myoma menorrhagia