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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03118037
Other study ID # CL 04878
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 14, 2017
Est. completion date December 2028

Study information

Verified date February 2023
Source Gynesonics
Contact Taraneh G Farazi, PhD
Phone 6502163878
Email tfarazi@gynesonics.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2028
Est. primary completion date July 2028
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Sonata System
Transcervical access for radiofrequency ablation of uterine fibroids

Locations

Country Name City State
Germany Frauenklinik Universitätsklinikum Jena Jena
Germany Klinik für Frauenheilkunde und Geburtshilfe Kempten
Germany Evangelisches Krankenhaus Köln-Weyertal gemeinnützige GmbH Köln
Germany MarienKrankenhaus Schwerte Frauenklinik Schwerte
Germany Josephs-Hospital Warendorf Warendorf
Germany Marien Hospital Witten Witten
Switzerland Spital Oberengadin Samedan
United Kingdom Addenbrookes Cambridge University Hospitals NHS Foundation Trust Cambridge
United Kingdom Liverpool Women's NHS Foundation Trust Liverpool

Sponsors (1)

Lead Sponsor Collaborator
Gynesonics

Countries where clinical trial is conducted

Germany,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Uterine Fibroid Symptom - Quality of Life UFS-QoL, validated fibroid specific assessment tool Pre-procedure and up to 5 years
Other 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.
Other Time to Return to Normal Daily Activity Questionnaire First two weeks post procedure
Other Time to Return to Sexual Activity Questionnaire First two weeks post procedure
Other Change in General Health Outcome EQ-5D standardized instrument for use as a measure of health outcome Pre-procedure and up to 5 years
Other 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
Other Subject Satisfaction Questionnaire At 1 year post procedure and up to 5 years
Other Overall Treatment Effect Questionnaire At 1 year post procedure and up to 5 years
Primary 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
Primary 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
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