Uterine Fibroid
Conditions
Keywords
Radiofrequency Ablation
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.
Interventions
DEVICESonata System
Transcervical access for radiofrequency ablation of uterine fibroids
Sponsors
Gynesonics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Return to Normal Daily Activity | First two weeks post procedure | Questionnaire |
| Time to Return to Sexual Activity | First two weeks post procedure | Questionnaire |
| Change in General Health Outcome | Pre-procedure and up to 5 years | EQ-5D standardized instrument for use as a measure of health outcome |
| Uterine Fibroid Symptom - Quality of Life | Pre-procedure and up to 5 years | UFS-QoL, validated fibroid specific assessment tool |
| Subject Satisfaction | At 1 year post procedure and up to 5 years | Questionnaire |
| Overall Treatment Effect | At 1 year post procedure and up to 5 years | Questionnaire |
| Work Productivity and Activity Impairment | Pre-procedure and up to 5 years | Standardized instrument for assessing activity/productivity impairment, commonly used in health economics outcomes research. The tool measure impairment in percentage. |
| Length of Stay | From admission to hospital discharge, up to four weeks. | Length of stay (in hours) for the treatment of fibroids with the Sonata System (which occurs at enrollment into the registry). |
Countries
Germany, Switzerland, United Kingdom
Outcome results
None listed