CompletedNot Applicable

Sonography Guided Transcervical Ablation of Uterine Fibroids

United States, Mexico147 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 range

25 Years – 50 Years

Sex

FEMALE

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)

Timeframe: Baseline and 12 Months

Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure

Timeframe: 12 Months

Trial details

NCT IDNCT02228174

SponsorGynesonics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10-18

Results submitted2018-11-26

View on ClinicalTrials.gov More Menorrhagia trials