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

Uterine Fibroids Clinical Trial

— OPEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844920
• Other study ID #: CL04897
• Status: Completed
• Start date: July 20, 2017
• Est. completion date: August 27, 2018

Study information

• Verified date: September 2019
• Source: Gynesonics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 27, 2018
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adhesions
• Leiomyoma
• Uterine Fibroids

Intervention

Device:
• Intrauterine ultrasound guided radio-frequency ablation
Radiofrequency ablation for the treatment of uterine fibroids

Locations

Country	Name	City	State
Germany	Klinikum Mannheim Universitäts- Frauenklinik Medizinische Fakultät Mannheim der Universität Heidelberg	Mannheim
Germany	Klinikum Oldenburg	Oldenburg
Germany	Universitätsklinikum Tübingen	Tübingen
Netherlands	Maxima Medisch Centrum (MMC)	Veldhoven
Switzerland	Universitätsklinik für Frauenheilkunde Inselspital Bern	Bern
United Kingdom	St. Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Gynesonics

Countries where clinical trial is conducted

Germany,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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