Clinical trial · Observational
Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry
Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)
NCT03118037CI-TRIAL-00083748SAGEterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Termination due to continued lack of patient compliance
Summary
Brief summary (as posted)
SAGE is an observational post market registry with the objective of characterizing long term outcomes after treatment of uterine fibroids with the Sonata System in real world clinical practice settings.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sonata System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Sonata
- description
- Women who undergo transcervical radiofrequency(RF) ablation with the Sonata System for treatment of their fibroids
- interventionNames
- Device: Sonata System
Primary outcomes (2)
- measure
- Incidence of Pregnancy and Pregnancy Outcomes
- timeFrame
- Up to 5 years-post procedure
- description
- Number of subjects with pregnancy and the number of pregnancies during the 5 year follow-up period. Outcome of each pregnancy including pregnancy outcomes, delivery route, antenatal and perinatal complications.
- measure
- Surgical Re-intervention for Heavy Menstrual Bleeding
- timeFrame
- Up to 5 years-post procedure
- description
- Number of subjects who had surgical re-intervention to treat heavy menstrual bleeding during the 5 year follow-up period.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have selected Sonata for treatment of symptomatic uterine fibroids or is participating in the OPEN study (Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids, NCT02844920, protocol # CL04897) or has completed participation in the OPEN study within the last 14 months * Speaks and reads a language for which questionnaires are available * Are greater than or equal to 18 years of age at the time of enrollment * Willing and able to read, understand and sign the informed consent form, to participate in the registry and to adhere to all registry study follow-up requirements Exclusion Criteria: * Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in the registry
References
Publications (1)
- DERIVEDChristoffel L, Romer T, Schiermeier S. Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results. Med Devices (Auckl). 2021 Mar 3;14:77-84. doi: 10.2147/MDER.S301166. eCollection 2021. PMID 33688276