Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry

Last updated: December 11, 2024
Sponsor: Gynesonics
Overall Status: Terminated

Phase

N/A

Condition

Sarcoma (Pediatric)

Uterina Myoma

Desmoid Tumors

Treatment

Sonata System

Clinical Study ID

NCT03118037
CL 04878
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have selected Sonata for treatment of symptomatic uterine fibroids or isparticipating in the OPEN study (Evaluation of Uterine Patency FollowingSonography-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, toparticipate in the registry and to adhere to all registry study follow-uprequirements

Exclusion

Exclusion Criteria:

  • Any reason for which, in the opinion of the Investigator, the individual studypatient is not appropriate or suitable for participation in the registry

Study Design

Total Participants: 182
Treatment Group(s): 1
Primary Treatment: Sonata System
Phase:
Study Start date:
June 14, 2017
Estimated Completion Date:
November 11, 2024

Study 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.

Connect with a study center

  • Frauenklinik Universitätsklinikum Jena

    Jena, 07743
    Germany

    Site Not Available

  • Klinik für Frauenheilkunde und Geburtshilfe

    Kempten, 87439
    Germany

    Site Not Available

  • Evangelisches Krankenhaus Köln-Weyertal gemeinnützige GmbH

    Köln, 50931
    Germany

    Site Not Available

  • MarienKrankenhaus Schwerte Frauenklinik

    Schwerte, 58239
    Germany

    Site Not Available

  • Josephs-Hospital Warendorf

    Warendorf, 48231
    Germany

    Site Not Available

  • Marien Hospital Witten

    Witten, 58452
    Germany

    Site Not Available

  • Spital Oberengadin

    Samedan,
    Switzerland

    Site Not Available

  • Addenbrookes Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Liverpool Women's NHS Foundation Trust

    Liverpool, L8 7SS
    United Kingdom

    Site Not Available

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