Sonography Guided Transcervical Ablation of Uterine Fibroids

Completed · Not applicable

Conditions studied: Menorrhagia

In brief

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

Key facts

Study ID

NCT02228174

Run by

Gynesonics

People needed

147

Starts

2014-10-01

Expected to finish

2019-11-01

Last updated by the study team

2020-02-11

Who can join

Age: 25 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kelly H. Roy M.D. P.C. — Phoenix, Arizona, United States
• Advanced Women's Health Institute — Denver, Colorado, United States
• Christiana Care Health Services, Inc. — Newark, Delaware, United States
• George Washington University Hospital — Washington D.C., District of Columbia, United States
• KO Clinical Research, LLC — Fort Lauderdale, Florida, United States
• Visions Clinical Research — Wellington, Florida, United States
• The Advanced Gynecologic Surgery Institute - Charles E. Miller, MD & Associates — Naperville, Illinois, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Wayne State University — Detroit, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Mercy Clinic, Minimally Invasive Gynecology — St Louis, Missouri, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Basque Women's Care — Albuquerque, New Mexico, United States
• Montefiore Medical Center — New York, New York, United States
• Carolina Women's Research and Wellness Center — Durham, North Carolina, United States
• Drexel University — Philadelphia, Pennsylvania, United States
• Magee Women's Hospital — Pittsburgh, Pennsylvania, United States
• Greenville Health System — Greenville, South Carolina, United States
• Baylor Research Institute — Fort Worth, Texas, United States
• Willowbend Health and Wellness Associates — Frisco, Texas, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León — Monterrey, N.L., Mexico

Full record on ClinicalTrials.gov

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