Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)

Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)

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.

Study Overview

• Status: Terminated
• Conditions: Uterine Fibroid
• Intervention / Treatment: Device: Sonata System

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.

• Study Type: Observational
• Enrollment (Actual): 182

Contacts and Locations

Study Locations

• Germany
  • Jena, Germany, 07743
    • Frauenklinik Universitätsklinikum Jena
  • Kempten, Germany, 87439
    • Klinik für Frauenheilkunde und Geburtshilfe
  • Köln, Germany, 50931
    • Evangelisches Krankenhaus Köln-Weyertal gemeinnützige GmbH
  • Schwerte, Germany, 58239
    • MarienKrankenhaus Schwerte Frauenklinik
  • Warendorf, Germany, 48231
    • Josephs-Hospital Warendorf
  • Witten, Germany, 58452
    • Marien Hospital Witten
• Switzerland
  • Samedan, Switzerland
    • Spital Oberengadin
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Cambridge University Hospitals NHS Foundation Trust
  • Liverpool, United Kingdom, L8 7SS
    • Liverpool Women's NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women who select to have their uterine fibroids treated with the Sonata System

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sonata; Women who undergo transcervical radiofrequency(RF) ablation with the Sonata System for treatment of their fibroids	Device: Sonata System; Transcervical access for radiofrequency ablation of uterine fibroids; Other Names: Transcervical RF Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Pregnancy and Pregnancy Outcomes	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.	Up to 5 years-post procedure
Surgical Re-intervention for Heavy Menstrual Bleeding	Number of subjects who had surgical re-intervention to treat heavy menstrual bleeding during the 5 year follow-up period.	Up to 5 years-post procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uterine Fibroid Symptom - Quality of Life	UFS-QoL, validated fibroid specific assessment tool	Pre-procedure and up to 5 years
Length of Stay	Length of stay (in hours) for the treatment of fibroids with the Sonata System (which occurs at enrollment into the registry).	From admission to hospital discharge, up to four weeks.
Time to Return to Normal Daily Activity	Questionnaire	First two weeks post procedure
Time to Return to Sexual Activity	Questionnaire	First two weeks post procedure
Change in General Health Outcome	EQ-5D standardized instrument for use as a measure of health outcome	Pre-procedure and up to 5 years
Work Productivity and Activity Impairment	Standardized instrument for assessing activity/productivity impairment, commonly used in health economics outcomes research. The tool measure impairment in percentage.	Pre-procedure and up to 5 years
Subject Satisfaction	Questionnaire	At 1 year post procedure and up to 5 years
Overall Treatment Effect	Questionnaire	At 1 year post procedure and up to 5 years

Collaborators and Investigators

• Sponsor: Gynesonics

Publications and helpful links

General Publications

• 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. Erratum In: Med Devices (Auckl). 2021 Mar 15;14:85. doi: 10.2147/MDER.S309722.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): November 11, 2024
• Study Completion (Actual): November 11, 2024

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Radiofrequency Ablation
• Additional Relevant MeSH Terms: Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Neurotransmitter Agents; Hypnotics and Sedatives; GABA Modulators; GABA Agents; Anticonvulsants; Zaleplon
• Other Study ID Numbers: CL 04878

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes