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Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry

NCT ID: NCT03118037

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-14

Study Completion Date

2024-11-11

Brief Summary

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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

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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.

Conditions

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Uterine Fibroid

Keywords

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Radiofrequency Ablation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sonata

Women who undergo transcervical radiofrequency(RF) ablation with the Sonata System for treatment of their fibroids

Sonata System

Intervention Type DEVICE

Transcervical access for radiofrequency ablation of uterine fibroids

Interventions

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Sonata System

Transcervical access for radiofrequency ablation of uterine fibroids

Intervention Type DEVICE

Other Intervention Names

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Transcervical RF Ablation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gynesonics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Evangelisches Krankenhaus Köln-Weyertal gemeinnützige GmbH

Cologne, , Germany

Site Status

Frauenklinik Universitätsklinikum Jena

Jena, , Germany

Site Status

Klinik für Frauenheilkunde und Geburtshilfe

Kempten, , Germany

Site Status

MarienKrankenhaus Schwerte Frauenklinik

Schwerte, , Germany

Site Status

Josephs-Hospital Warendorf

Warendorf, , Germany

Site Status

Marien Hospital Witten

Witten, , Germany

Site Status

Spital Oberengadin

Samedan, , Switzerland

Site Status

Addenbrookes Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Site Status

Liverpool Women's NHS Foundation Trust

Liverpool, , United Kingdom

Site Status

Countries

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Germany Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 33688276 (View on PubMed)

Other Identifiers

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CL 04878

Identifier Type: -

Identifier Source: org_study_id