N/A
N=37
Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
Uterine Fibroids · Adhesions
Bottom Line
View on ClinicalTrials.gov: NCT02844920 ↗Enrolled (actual)
37
Serious AEs
2.7%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids — 34 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Intrauterine ultrasound guided radio-frequency ablation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gynesonics
- Primary completion
- Aug 2018
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 | — |
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.
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
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.