Study to Assess the Safety and Efficacy of the IUB SEAD™ Device : Pre-pivotal, Randomized Study to Assess the Safety and Efficacy of the IUB SEAD™ Device in Women Suffering From Abnormal Uterine Bleeding
Chronic abnormal uterine bleeding (AUB), involving menstrual bleeding of abnormal quantity, duration, or schedule, is experienced by 10-35% of women, and can markedly impact everyday activities, can lead to iron deficiency and in severe cases, can necessitate emergency medical care.While pharmacologic treatment options exist, some women desire a treatment that requires less maintenance or is definitive. Endometrial ablation is a minimally invasive approach applied to manage AUB and can be performed using resectoscopic instruments or with a non-resectoscopic approach, in which the device is inserted into the uterine cavity and delivers energy to uniformly destroy the uterine lining. Non-resectoscopic endometrial ablation has become an accepted office-based procedure, but requires training in administration and response to complications of conscious sedation and of assisting personnel.The IUB SEAD™ device is a novel Spherical Endometrial Ablation Device, developed to allow for a simple, office-based chemical endometrial ablation to treat AUB. The suggested procedure is expected to be simpler than the currently available ablation methods and to result in a clinically meaningful delay or abolishment of the need for hysterectomy.
| Medienart: |
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Klinische Studie| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
ClinicalTrials.gov - (2023) vom: 08. Nov. Zur Gesamtaufnahme - year:2023 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: May 8, 2020, Last downloaded: ClinicalTrials.gov processed this data on November 15, 2023, Last updated: November 15, 2023 |
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| Study ID: |
NCT04381416 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG003386465 |
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| 520 | |a Chronic abnormal uterine bleeding (AUB), involving menstrual bleeding of abnormal quantity, duration, or schedule, is experienced by 10-35% of women, and can markedly impact everyday activities, can lead to iron deficiency and in severe cases, can necessitate emergency medical care.While pharmacologic treatment options exist, some women desire a treatment that requires less maintenance or is definitive. Endometrial ablation is a minimally invasive approach applied to manage AUB and can be performed using resectoscopic instruments or with a non-resectoscopic approach, in which the device is inserted into the uterine cavity and delivers energy to uniformly destroy the uterine lining. Non-resectoscopic endometrial ablation has become an accepted office-based procedure, but requires training in administration and response to complications of conscious sedation and of assisting personnel.The IUB SEAD™ device is a novel Spherical Endometrial Ablation Device, developed to allow for a simple, office-based chemical endometrial ablation to treat AUB. The suggested procedure is expected to be simpler than the currently available ablation methods and to result in a clinically meaningful delay or abolishment of the need for hysterectomy | ||
| 650 | 2 | |a Uterine Hemorrhage | |
| 650 | 2 | |a Hemorrhage | |
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| 650 | 4 | |a Recruitment Status: Completed | |
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