Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results

Ladina Christoffel,1 Thomas Römer,2 Sven Schiermeier3 1Spital Oberengadin, Samedan, Switzerland; 2Evangelisches Klinikum Köln-Weyertal, Köln, Germany; 3Marien-Hospital, Witten, GermanyCorrespondence: Ladina ChristoffelSpital Oberengadin, Via Nouva 3, Samedan, CH-7503, Swit...

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Autores principales:	Christoffel L, Römer T, Schiermeier S
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	leiomyoma myoma radiofrequency ablation sage sonata transcervical fibroid ablation uterine fibroid Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/515304e0f7da4f0393cc89741e8426ce
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spelling	oai:doaj.org-article:515304e0f7da4f0393cc89741e8426ce2021-12-02T10:37:31ZTranscervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results1179-1470https://doaj.org/article/515304e0f7da4f0393cc89741e8426ce2021-03-01T00:00:00Zhttps://www.dovepress.com/transcervical-radiofrequency-ablation-of-uterine-fibroids-global-regis-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Ladina Christoffel,1 Thomas Römer,2 Sven Schiermeier3 1Spital Oberengadin, Samedan, Switzerland; 2Evangelisches Klinikum Köln-Weyertal, Köln, Germany; 3Marien-Hospital, Witten, GermanyCorrespondence: Ladina ChristoffelSpital Oberengadin, Via Nouva 3, Samedan, CH-7503, SwitzerlandTel +41 81851 8111Email Christoffel.Ladina@spital.netBackground: Transcervical fibroid ablation (TFA) is a minimally invasive, effective treatment of symptomatic uterine fibroids that utilizes intrauterine ultrasound for imaging and radiofrequency energy for ablation. Outcomes reported with TFA have been positive, with significant reductions in fibroid volume, improvements in symptom severity and health-related quality of life, and low complication and surgical reintervention rates. The SAGE registry characterizes the long-term (5-year) outcomes of TFA when used to treat symptomatic uterine fibroids in real-world usage.Methods/Design: SAGE is an ongoing postmarket global registry involving up to 50 sites and up to 500 women who select TFA with the Sonata system for treatment of symptomatic uterine fibroids. Patients are followed for 5 years. Main outcomes include symptom severity score and health-related quality of life subscales of the UFS-QoL, general health status on the EQ-5D, perceived treatment benefit, treatment satisfaction, work and activity patterns, overall patient treatment outcome, adverse events, pregnancy incidence and outcomes, and surgical reinterventions for heavy menstrual bleeding.Discussion: The SAGE registry represents the largest known study of TFA for uterine fibroids and will generate up to 2500 patient-years of outcome data. Preliminary results from the first 160 treated women suggest broad applicability of TFA to a wide range of fibroid types and sizes and an excellent safety profile, with a device-related adverse event rate of 0.6% and a serious procedure-related adverse event rate of 0.6%. Of the 241 fibroids treated, 10% were submucous, 52% transmural, 28% intramural, and 10% subserous. Ablated fibroid diameters ranged from < 1 cm to > 10 cm, with 27% of fibroids having maximum diameters > 5 cm. The real-world experience from SAGE will strengthen the existing evidence on the durability of TFA in providing meaningful relief from uterine fibroid symptoms and will have important clinical and economic implications for patients, physicians, and healthcare payers.Trial Registration: https://clinicaltrials.gov, NCT03118037. Registered on 18 April 2017.Keywords: leiomyoma, myoma, radiofrequency ablation, SAGE, Sonata, transcervical fibroid ablation, uterine fibroidChristoffel LRömer TSchiermeier SDove Medical Pressarticleleiomyomamyomaradiofrequency ablationsagesonatatranscervical fibroid ablationuterine fibroidMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 14, Pp 77-84 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	leiomyoma myoma radiofrequency ablation sage sonata transcervical fibroid ablation uterine fibroid Medical technology R855-855.5
spellingShingle	leiomyoma myoma radiofrequency ablation sage sonata transcervical fibroid ablation uterine fibroid Medical technology R855-855.5 Christoffel L Römer T Schiermeier S Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results
description	Ladina Christoffel,1 Thomas Römer,2 Sven Schiermeier3 1Spital Oberengadin, Samedan, Switzerland; 2Evangelisches Klinikum Köln-Weyertal, Köln, Germany; 3Marien-Hospital, Witten, GermanyCorrespondence: Ladina ChristoffelSpital Oberengadin, Via Nouva 3, Samedan, CH-7503, SwitzerlandTel +41 81851 8111Email Christoffel.Ladina@spital.netBackground: Transcervical fibroid ablation (TFA) is a minimally invasive, effective treatment of symptomatic uterine fibroids that utilizes intrauterine ultrasound for imaging and radiofrequency energy for ablation. Outcomes reported with TFA have been positive, with significant reductions in fibroid volume, improvements in symptom severity and health-related quality of life, and low complication and surgical reintervention rates. The SAGE registry characterizes the long-term (5-year) outcomes of TFA when used to treat symptomatic uterine fibroids in real-world usage.Methods/Design: SAGE is an ongoing postmarket global registry involving up to 50 sites and up to 500 women who select TFA with the Sonata system for treatment of symptomatic uterine fibroids. Patients are followed for 5 years. Main outcomes include symptom severity score and health-related quality of life subscales of the UFS-QoL, general health status on the EQ-5D, perceived treatment benefit, treatment satisfaction, work and activity patterns, overall patient treatment outcome, adverse events, pregnancy incidence and outcomes, and surgical reinterventions for heavy menstrual bleeding.Discussion: The SAGE registry represents the largest known study of TFA for uterine fibroids and will generate up to 2500 patient-years of outcome data. Preliminary results from the first 160 treated women suggest broad applicability of TFA to a wide range of fibroid types and sizes and an excellent safety profile, with a device-related adverse event rate of 0.6% and a serious procedure-related adverse event rate of 0.6%. Of the 241 fibroids treated, 10% were submucous, 52% transmural, 28% intramural, and 10% subserous. Ablated fibroid diameters ranged from < 1 cm to > 10 cm, with 27% of fibroids having maximum diameters > 5 cm. The real-world experience from SAGE will strengthen the existing evidence on the durability of TFA in providing meaningful relief from uterine fibroid symptoms and will have important clinical and economic implications for patients, physicians, and healthcare payers.Trial Registration: https://clinicaltrials.gov, NCT03118037. Registered on 18 April 2017.Keywords: leiomyoma, myoma, radiofrequency ablation, SAGE, Sonata, transcervical fibroid ablation, uterine fibroid
format	article
author	Christoffel L Römer T Schiermeier S
author_facet	Christoffel L Römer T Schiermeier S
author_sort	Christoffel L
title	Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results
title_short	Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results
title_full	Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results
title_fullStr	Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results
title_full_unstemmed	Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results
title_sort	transcervical radiofrequency ablation of uterine fibroids global registry (sage): study protocol and preliminary results
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/515304e0f7da4f0393cc89741e8426ce
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Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results

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