Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry

Uterine Fibroid Clinical Trial

— SAGE  

Official title:

Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03118037
• Other study ID #: CL 04878
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroid

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