Evaluation Of Uterine Patency following Sonography-guided Transcervical Ablation of Fibroids

Completed

Conditions: Synechiae
formation of adhesion
10013326

Registration Number: NL-OMON45454

Lead Sponsor: Gynesonics, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

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)
- Are * 18 years of age at the time of enrollment
- 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of the formation of new intrauterine synechiae at six weeks will be<br /><br>assessed.<br /><br>Identified adhesions will be classified per the European Society of<br /><br>Hysteroscopy (ESH) scoring system. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>In addition to the documentation of the presence of adhesions after sonata<br /><br>treatment, the effect of the sonata treatment on recovery after treatment<br /><br>(treatment recovery questionnaire), on the subjects quality of live (E-Q-5D<br /><br>questionnaire) and subject satisfaction with treatment (Subject Satisfaction<br /><br>and Overall Treatment Effect questionnaire) will be assessed. Furthermore<br /><br>adverse events and surgical re-interventions will be documented</p><br>