formation of adhesion Synechiae
Conditions
Interventions
hysteroscopy
intrauterine synechiae
uterine fibroids
Sponsors
Gynesonics, Inc
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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) - Are * 18 years of age at the time of enrollment - Willing and able to read, understand, and sign the informed consent form and to adhere to all study follow-up requirements
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of the formation of new intrauterine synechiae at six weeks will be assessed. Identified adhesions will be classified per the European Society of Hysteroscopy (ESH) scoring system. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to the documentation of the presence of adhesions after sonata treatment, the effect of the sonata treatment on recovery after treatment (treatment recovery questionnaire), on the subjects quality of live (E-Q-5D questionnaire) and subject satisfaction with treatment (Subject Satisfaction and Overall Treatment Effect questionnaire) will be assessed. Furthermore adverse events and surgical re-interventions will be documented | — |
Countries
Germany, Netherlands, Switzerland, United Kingdom
Outcome results
None listed