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

Launched by GYNESONICS · Jul 22, 2016

Keywords

ClinConnect Summary

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.

Gender

FEMALE

Eligibility criteria

• 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