Spots Global Cancer Trial Database for Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids

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Trial Identification

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

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

Study ID: NCT02844920

Conditions

Uterine Fibroids

Adhesions

Interventions

Intrauterine ultrasound guided radio-frequency ablation

Study Description

Brief Summary: 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: 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.