Sonography Guided Transcervical Ablation of Uterine Fibroids
United States147 participantsStarted 2014-10
Plain-language summary
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
Who can participate
Age range25 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* previou…
What they're measuring
1
Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)
Timeframe: Baseline and 12 Months
2
Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure