Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)
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|ClinicalTrials.gov Identifier: NCT03118037|
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment|
|Uterine Fibroid||Device: Sonata System|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)|
|Actual Study Start Date :||June 14, 2017|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||December 2023|
Women who undergo transcervical radiofrequency(RF) ablation with the Sonata System for treatment of their fibroids
Device: Sonata System
Transcervical access for radiofrequency ablation of uterine fibroids
Other Name: Transcervical RF Ablation
- Incidence of Pregnancy and Pregnancy Outcomes [ Time Frame: Up to 5 years-post procedure ]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.
- Surgical Re-intervention for Heavy Menstrual Bleeding [ Time Frame: Up to 5 years-post procedure ]Number of subjects who had surgical re-intervention to treat heavy menstrual bleeding during the 5 year follow-up period.
- Uterine Fibroid Symptom - Quality of Life [ Time Frame: Pre-procedure and up to 5 years ]UFS-QoL, validated fibroid specific assessment tool
- Length of Stay [ Time Frame: From admission to hospital discharge, up to four weeks. ]Length of stay (in hours) for the treatment of fibroids with the Sonata System (which occurs at enrollment into the registry).
- Time to Return to Normal Daily Activity [ Time Frame: First two weeks post procedure ]Questionnaire
- Time to Return to Sexual Activity [ Time Frame: First two weeks post procedure ]Questionnaire
- Change in General Health Outcome [ Time Frame: Pre-procedure and up to 5 years ]EQ-5D standardized instrument for use as a measure of health outcome
- Work Productivity and Activity Impairment [ Time Frame: Pre-procedure and up to 5 years ]Standardized instrument for assessing activity/productivity impairment, commonly used in health economics outcomes research. The tool measure impairment in percentage.
- Subject Satisfaction [ Time Frame: At 1 year post procedure and up to 5 years ]Questionnaire
- Overall Treatment Effect [ Time Frame: At 1 year post procedure and up to 5 years ]Questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118037
|Contact: Taraneh G Farazi, PhDemail@example.com|
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