Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids

Study Overview
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Brief Summary
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This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.

Detailed Description
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Patients who agree to participate in this observational trial will have selected fibroid treatment with the Sonata System. Research participants will undergo hysteroscopy at 6 weeks following treatment to evaluate presence or absence of intrauterine adhesions. Research participants will be asked to complete a quality of life questionnaire prior to and 6 weeks following treatment. Research participants will also complete a satisfaction survey and a diary that tracks their return to normal daily activities.

Official Title
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Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids

Conditions
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Uterine Fibroids, Adhesions

Intervention / Treatment
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* Device: Intrauterine ultrasound guided radio-frequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have selected Sonata for treatment of fibroids in the presence of heavy menstrual bleeding Presence of at least one submucous myoma (type 1, type 2) or transmural fibroid (type 2-5) Willing and able to read, understand, and sign the informed consent form and to adhere to all study follow-up requirements Exclusion Criteria: Preexisting adhesions within the endometrial cavity as indicated by an ESH score ≥ I as determined by the investigator One or more Type 0 fibroids and/or endometrial polyps of any size Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fibroid Treatment<br>Intrauterine ultrasound guided radio-frequency ablation | Device: Intrauterine ultrasound guided radio-frequency ablation<br>* Radiofrequency ablation for the treatment of uterine fibroids<br>* Other names: Sonata System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids | Hysteroscopic evaluation by independent readers to determine the presence or absence of adhesions following transcervical RF ablation of fibroids with the Sonata system in participants who completed the follow-up assessment AND evaluable hysteroscopy videos. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated | As the risk of adhesion formation is higher when apposing fibroids are treated, this outcome measure assesses adhesiogenesis in the subgroup of the population who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated. | 6 weeks |