NCT03118037

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
3 countries

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 14, 2017

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2024

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

7.4 years

First QC Date

March 27, 2017

Last Update Submit

December 11, 2024

Conditions

Uterine Fibroid

Keywords

Radiofrequency Ablation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Uterine Fibroid Symptom - Quality of Life

    Pre-procedure and up to 5 years

  • Length of Stay

    From admission to hospital discharge, up to four weeks.

  • Time to Return to Normal Daily Activity

    First two weeks post procedure

  • +5 more other outcomes

Study Arms (1)

Sonata

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

Device: Sonata System

Interventions

Sonata SystemDEVICE

Transcervical access for radiofrequency ablation of uterine fibroids

Also known as: Transcervical RF Ablation
Sonata

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women with diagnosed uterine fibroids are eligible to participate
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Evangelisches Krankenhaus Köln-Weyertal gemeinnützige GmbH

Cologne, 50931, Germany

Location

Frauenklinik Universitätsklinikum Jena

Jena, 07743, Germany

Location

Klinik für Frauenheilkunde und Geburtshilfe

Kempten, 87439, Germany

Location

MarienKrankenhaus Schwerte Frauenklinik

Schwerte, 58239, Germany

Location

Josephs-Hospital Warendorf

Warendorf, 48231, Germany

Location

Marien Hospital Witten

Witten, 58452, Germany

Location

Spital Oberengadin

Samedan, Switzerland

Location

Addenbrookes Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Liverpool Women's NHS Foundation Trust

Liverpool, L8 7SS, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 33688276DERIVED

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2017

First Posted

April 18, 2017

Study Start

June 14, 2017

Primary Completion

November 11, 2024

Study Completion

November 11, 2024

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)DE(6)CH(1)