N/A Completed N=37

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

Source: ClinicalTrials.gov NCT02844920 ↗

Enrolled (actual)

Serious AEs

2.7%

Results posted

Sep 2019

Primary outcomePrimary: Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids — 34 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids	34	—
SECONDARY Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated	6	—

Eligibility 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)
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02844920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.