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

Completed

• Conditions: Adhesions; Uterine Fibroids
• Interventions: Device: Intrauterine ultrasound guided radio-frequency ablation

• Registration Number: NCT02844920
• Lead Sponsor: Gynesonics

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.

Study Timeline

• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-26
• Study Start: 2017-07-20
• Primary Completion: 2018-08-27
• Study Completion: 2018-08-27
• Results First Submitted: 2019-08-12
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-18
• Last Update Submitted: 2019-09-18
• Results First Posted: 2019-09-20
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fibroid Treatment	Intrauterine ultrasound guided radio-frequency ablation	Intrauterine ultrasound guided radio-frequency ablation

Primary Outcome Measures

Name	Time	Method
Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids	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 Outcome Measures

Name	Time	Method
Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated	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.

Trial Locations

Locations (6)

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

Klinikum Oldenburg; 🇩🇪 Oldenburg, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Universitätsklinik für Frauenheilkunde Inselspital Bern; 🇨🇭 Bern, Switzerland

St. Mary's Hospital; 🇬🇧 London, United Kingdom

Maxima Medisch Centrum (MMC); 🇳🇱 Veldhoven, Netherlands