Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids (OPEN)

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.

Study Overview

• Status: Completed
• Conditions: Uterine Fibroids; Adhesions
• Intervention / Treatment: Device: Intrauterine ultrasound guided radio-frequency ablation

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 Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany, 68167
    • Klinikum Mannheim Universitäts- Frauenklinik Medizinische Fakultät Mannheim der Universität Heidelberg
  • Oldenburg, Germany
    • Klinikum Oldenburg
  • Tübingen, Germany
    • Universitatsklinikum Tubingen
• Netherlands
  • Veldhoven, Netherlands
    • Maxima Medisch Centrum (MMC)
• Switzerland
  • Bern, Switzerland
    • Universitätsklinik für Frauenheilkunde Inselspital Bern
• United Kingdom
  • London, United Kingdom
    • St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Individuals who desire treatment of intrauterine fibroids with RF ablation via the Sonata System.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fibroid Treatment; Intrauterine ultrasound guided radio-frequency ablation	Device: Intrauterine ultrasound guided radio-frequency ablation; Radiofrequency ablation for the treatment of uterine fibroids; Other Names: Sonata System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Collaborators and Investigators

• Sponsor: Gynesonics

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2017
• Primary Completion (Actual): August 27, 2018
• Study Completion (Actual): August 27, 2018

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: CL04897

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This observational study is intended to view the group as an entirety, individual participant data will be analyzed for adhesions but will not be shared independently.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes