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

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.

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Key information

Conditions

Uterine Fibroids Adhesions Cicatrix Fibrosis Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Tissue Adhesions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Klinikum Mannheim Universitäts- Frauenklinik Medizinische Fakultät Mannheim der Universität Heidelberg, Mannheim, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrauterine ultrasound guided radio-frequency ablation

Device

Radiofrequency ablation for the treatment of uterine fibroids

Other names: Sonata System

Primary outcomes

Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids

Time frame: 6 weeks

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.

Secondary outcomes

Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated

Time frame: 6 weeks

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.

Sponsors and collaborators

Lead sponsor

Gynesonics

Industry

Registry information

Acronym: OPEN

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Jul 26, 2016
Registry last updated: Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed