Clinical trial · Observational
Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
NCT02844920CI-TRIAL-00040739OPENcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adhesions | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intrauterine ultrasound guided radio-frequency ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Fibroid Treatment
- description
- Intrauterine ultrasound guided radio-frequency ablation
- interventionNames
- Device: Intrauterine ultrasound guided radio-frequency ablation
Primary outcomes (1)
- measure
- Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids
- timeFrame
- 6 weeks
- description
- 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.
Secondary outcomes (1)
- measure
- Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.