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Study Protocol of a Prospective, Monocentric, Single-Arm Study Investigating the Safety and Efficacy of Local Ablation of Symptomatic Uterine Fibroids with US-Guided High-Intensity Focused Ultrasound (HIFU)

Uterine fibroids are the most common benign tumors of the uterus. Approximately 20–50% of women with myomas experience a variety of symptoms such as vaginal bleeding, abdominal pain, pelvic pain and pressure, and urological problems, possibly interfering with fertility and pregnancy. Although surger...

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Autores principales: Matlac, Dieter M., Tonguc, Tolga, Mutschler, Nikola, Recker, Florian, Ramig, Olga, Strunk, Holger M., Dell, Tatjana, Pieper, Claus C., Coenen, Martin, Fuhrmann, Christine, Vautey, Oregan, Egger, Eva-Katharina, Küppers, Jim, Conrad, Rupert, Essler, Markus, Mustea, Alexander, Marinova, Milka
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10531700/
https://www.ncbi.nlm.nih.gov/pubmed/37762868
http://dx.doi.org/10.3390/jcm12185926
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author Matlac, Dieter M.
Tonguc, Tolga
Mutschler, Nikola
Recker, Florian
Ramig, Olga
Strunk, Holger M.
Dell, Tatjana
Pieper, Claus C.
Coenen, Martin
Fuhrmann, Christine
Vautey, Oregan
Egger, Eva-Katharina
Küppers, Jim
Conrad, Rupert
Essler, Markus
Mustea, Alexander
Marinova, Milka
author_facet Matlac, Dieter M.
Tonguc, Tolga
Mutschler, Nikola
Recker, Florian
Ramig, Olga
Strunk, Holger M.
Dell, Tatjana
Pieper, Claus C.
Coenen, Martin
Fuhrmann, Christine
Vautey, Oregan
Egger, Eva-Katharina
Küppers, Jim
Conrad, Rupert
Essler, Markus
Mustea, Alexander
Marinova, Milka
author_sort Matlac, Dieter M.
collection PubMed
description Uterine fibroids are the most common benign tumors of the uterus. Approximately 20–50% of women with myomas experience a variety of symptoms such as vaginal bleeding, abdominal pain, pelvic pain and pressure, and urological problems, possibly interfering with fertility and pregnancy. Although surgery remains the standard treatment option for fibroids, non-invasive therapeutic options, such as high-intensity focused ultrasound (HIFU), have emerged over the last dec ade. During HIFU, ultrasound is focused on the target tissue causing coagulation necrosis. HIFU has, meanwhile, become an established method for treating uterine fibroids in many countries. Clinical data have shown that it effectively alleviates fibroid-related symptoms and reduces fibroid size with a very low rate of side effects. However, there is a lack of data on how this treatment affects laboratory parameters and structural features of uterine tissue. As our center is the only one in German-speaking countries where ultrasound-guided HIFU technology is currently established, the aim of this prospective, monocentric, single-arm trial is not only to evaluate the safety and efficacy of local US-guided HIFU in symptomatic uterine fibroid patients according to GCP standards but also to explore its effects on blood parameters and the structural integrity of uterine tissue using elastographic methods.
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spelling pubmed-105317002023-09-28 Study Protocol of a Prospective, Monocentric, Single-Arm Study Investigating the Safety and Efficacy of Local Ablation of Symptomatic Uterine Fibroids with US-Guided High-Intensity Focused Ultrasound (HIFU) Matlac, Dieter M. Tonguc, Tolga Mutschler, Nikola Recker, Florian Ramig, Olga Strunk, Holger M. Dell, Tatjana Pieper, Claus C. Coenen, Martin Fuhrmann, Christine Vautey, Oregan Egger, Eva-Katharina Küppers, Jim Conrad, Rupert Essler, Markus Mustea, Alexander Marinova, Milka J Clin Med Protocol Uterine fibroids are the most common benign tumors of the uterus. Approximately 20–50% of women with myomas experience a variety of symptoms such as vaginal bleeding, abdominal pain, pelvic pain and pressure, and urological problems, possibly interfering with fertility and pregnancy. Although surgery remains the standard treatment option for fibroids, non-invasive therapeutic options, such as high-intensity focused ultrasound (HIFU), have emerged over the last dec ade. During HIFU, ultrasound is focused on the target tissue causing coagulation necrosis. HIFU has, meanwhile, become an established method for treating uterine fibroids in many countries. Clinical data have shown that it effectively alleviates fibroid-related symptoms and reduces fibroid size with a very low rate of side effects. However, there is a lack of data on how this treatment affects laboratory parameters and structural features of uterine tissue. As our center is the only one in German-speaking countries where ultrasound-guided HIFU technology is currently established, the aim of this prospective, monocentric, single-arm trial is not only to evaluate the safety and efficacy of local US-guided HIFU in symptomatic uterine fibroid patients according to GCP standards but also to explore its effects on blood parameters and the structural integrity of uterine tissue using elastographic methods. MDPI 2023-09-12 /pmc/articles/PMC10531700/ /pubmed/37762868 http://dx.doi.org/10.3390/jcm12185926 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Protocol
Matlac, Dieter M.
Tonguc, Tolga
Mutschler, Nikola
Recker, Florian
Ramig, Olga
Strunk, Holger M.
Dell, Tatjana
Pieper, Claus C.
Coenen, Martin
Fuhrmann, Christine
Vautey, Oregan
Egger, Eva-Katharina
Küppers, Jim
Conrad, Rupert
Essler, Markus
Mustea, Alexander
Marinova, Milka
Study Protocol of a Prospective, Monocentric, Single-Arm Study Investigating the Safety and Efficacy of Local Ablation of Symptomatic Uterine Fibroids with US-Guided High-Intensity Focused Ultrasound (HIFU)
title Study Protocol of a Prospective, Monocentric, Single-Arm Study Investigating the Safety and Efficacy of Local Ablation of Symptomatic Uterine Fibroids with US-Guided High-Intensity Focused Ultrasound (HIFU)
title_full Study Protocol of a Prospective, Monocentric, Single-Arm Study Investigating the Safety and Efficacy of Local Ablation of Symptomatic Uterine Fibroids with US-Guided High-Intensity Focused Ultrasound (HIFU)
title_fullStr Study Protocol of a Prospective, Monocentric, Single-Arm Study Investigating the Safety and Efficacy of Local Ablation of Symptomatic Uterine Fibroids with US-Guided High-Intensity Focused Ultrasound (HIFU)
title_full_unstemmed Study Protocol of a Prospective, Monocentric, Single-Arm Study Investigating the Safety and Efficacy of Local Ablation of Symptomatic Uterine Fibroids with US-Guided High-Intensity Focused Ultrasound (HIFU)
title_short Study Protocol of a Prospective, Monocentric, Single-Arm Study Investigating the Safety and Efficacy of Local Ablation of Symptomatic Uterine Fibroids with US-Guided High-Intensity Focused Ultrasound (HIFU)
title_sort study protocol of a prospective, monocentric, single-arm study investigating the safety and efficacy of local ablation of symptomatic uterine fibroids with us-guided high-intensity focused ultrasound (hifu)
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10531700/
https://www.ncbi.nlm.nih.gov/pubmed/37762868
http://dx.doi.org/10.3390/jcm12185926
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