Clinical trial NCT03118037: Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry
Official title: Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Uterine Fibroid
Keywords: Radiofrequency Ablation
Lead sponsor: Gynesonics
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who select to have their uterine fibroids treated with the Sonata System

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Pregnancy and Pregnancy Outcomes
timeFrame: Up to 5 years-post procedure
measure: Surgical Re-intervention for Heavy Menstrual Bleeding
timeFrame: Up to 5 years-post procedure
Secondary outcomes:
Other outcomes:
measure: Uterine Fibroid Symptom - Quality of Life
timeFrame: Pre-procedure and up to 5 years
measure: Length of Stay
timeFrame: From admission to hospital discharge, up to four weeks.
measure: Time to Return to Normal Daily Activity
timeFrame: First two weeks post procedure
measure: Time to Return to Sexual Activity
timeFrame: First two weeks post procedure
measure: Change in General Health Outcome
timeFrame: Pre-procedure and up to 5 years
measure: Work Productivity and Activity Impairment
timeFrame: Pre-procedure and up to 5 years
measure: Subject Satisfaction
timeFrame: At 1 year post procedure and up to 5 years
measure: Overall Treatment Effect
timeFrame: At 1 year post procedure and up to 5 years
Locations:
city: Jena
country: Germany
facility: Frauenklinik Universitätsklinikum Jena
city: Kempten
country: Germany
facility: Klinik für Frauenheilkunde und Geburtshilfe
city: Köln
country: Germany
facility: Evangelisches Krankenhaus Köln-Weyertal gemeinnützige GmbH
city: Schwerte
country: Germany
facility: MarienKrankenhaus Schwerte Frauenklinik
city: Warendorf
country: Germany
facility: Josephs-Hospital Warendorf
city: Witten
country: Germany
facility: Marien Hospital Witten
city: Samedan
country: Switzerland
facility: Spital Oberengadin
city: Cambridge
country: United Kingdom
facility: Addenbrookes Cambridge University Hospitals NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Liverpool Women's NHS Foundation Trust
Study officials:
References:
citation: Christoffel 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.