Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry
- Conditions
- Uterine Fibroid
- Interventions
- Device: Sonata System
- Registration Number
- NCT03118037
- Lead Sponsor
- Gynesonics
- Brief Summary
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.
- Detailed Description
Patients whom have selected the CE-marked Sonata system for treatment of fibroids will be approached for study participation. Participation in the trial will consist of data collection in the form of questionnaires prior to and after the treatment at the following intervals: pre-procedure, 4 weeks, 1, 2, 3, 4 and 5 years following treatment.
The following data points will be collected: Length of stay, time to return to normal activities (Treatment Recovery Questionnaire), time to return to sexual activity (Treatment Recovery Questionnaire), change in fibroid symptom severity and quality of life (UFS-QOL), change in general health outcome (EQ-5D), work productivity and activity impairment (WPAI), subject satisfaction and overall treatment effect (Overall Treatment Effect and Satisfaction Questionnaire), pregnancy occurrence and outcome, non-medical re-intervention, adverse events related to the device/procedure.
Validated questionnaires are used where appropriate (UFS-QOL, E1-5D and WPAI). Double data entry will occur to ensure accurate capture of subject reported data. Monitoring will occur throughout the course of the trial to ensure adherence to the protocol.
As an observational trial, there are no pre-specified statistically powered endpoints.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 182
- 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
- Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in the registry
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sonata Sonata System Women who undergo transcervical radiofrequency(RF) ablation with the Sonata System for treatment of their fibroids
- Primary Outcome Measures
Name Time Method Incidence of Pregnancy and Pregnancy Outcomes Up to 5 years-post procedure 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.
Surgical Re-intervention for Heavy Menstrual Bleeding Up to 5 years-post procedure Number of subjects who had surgical re-intervention to treat heavy menstrual bleeding during the 5 year follow-up period.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Frauenklinik Universitätsklinikum Jena
🇩🇪Jena, Germany
Klinik für Frauenheilkunde und Geburtshilfe
🇩🇪Kempten, Germany
Evangelisches Krankenhaus Köln-Weyertal gemeinnützige GmbH
🇩🇪Köln, Germany
MarienKrankenhaus Schwerte Frauenklinik
🇩🇪Schwerte, Germany
Josephs-Hospital Warendorf
🇩🇪Warendorf, Germany
Marien Hospital Witten
🇩🇪Witten, Germany
Spital Oberengadin
🇨🇭Samedan, Switzerland
Addenbrookes Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Liverpool Women's NHS Foundation Trust
🇬🇧Liverpool, United Kingdom