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

Gynesonics

Status

Completed

Conditions

Uterine Fibroids

Adhesions

Treatments

Device: Intrauterine ultrasound guided radio-frequency ablation

Study type

Observational

Funder types

Industry

Identifiers

NCT02844920

CL04897

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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