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

Gynesonics37 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Uterine Fibroids Adhesions

Interventions

Intrauterine ultrasound guided radio-frequency ablationDEVICE

Radiofrequency ablation for the treatment of uterine fibroids

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Klinikum Mannheim Universitäts- Frauenklinik Medizinische Fakultät Mannheim der Universität Heidelberg

Mannheim, Germany

Klinikum Oldenburg

Oldenburg, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Maxima Medisch Centrum (MMC)

Veldhoven, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: 6 weeks

Secondary Outcomes

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.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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