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Набор по приглашению NCT07217353

The Use of a Novel Vaginal Speculum for Endometrial Biopsies

Без фазы С лечением Endometrial Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Bouquet Speculum.
Кому может быть актуально
Состояния в реестре: Endometrial Cancer. Базовые параметры: 18 лет — 90 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The objective of this clinical trial is to determine if a newly-designed and FDA-cleared vaginal speculum (the Bouquet Speculum) will provide better visualization of the cervical os, be easier and more efficient to use, provide more consistent outcomes and decrease the discomfort associated with endometrial biopsy procedures.

Подробное описание

To answer the question, "How does the Bouquet speculum compare to a two-bladed speculum in terms of patient comfort, provider visualization, ease of use, and accuracy for obtaining samples for in-office endometrial biopsies for patients with endometrial cancer requiring follow up procedures?" the investigators will have an observational study of 100 women aged 18-90 years old that have previously had an endometrial biopsy with the use of a two-bladed speculum. Providers (physicians, physician's assistants, and nurse practitioners) at Minnesota Oncology Clinics will be educated on how to use the Bouquet speculum via a Zoom training session, a video presentation, and step-by-step instructional page that has been used in previous studies on the product. The providers will use the Bouquet speculum for endometrial biopsies on patients that consent to the study that come into the clinic for the procedure. The providers will do the procedures in the same way as they usually do but will use the Bouquet speculum instead of a two-bladed speculum.

To analyze the question, this research will measure the variables of patient comfort level, and provider ease-of-use with the Bouquet speculum, the extent of visualization of the cervix, and accuracy of sampling of the endometrium lining (the necessary result of an endometrial biopsy). The variables of patient weight and parity will be included in the patient survey to determine if they have an effect on the outcomes of visualization, ease-of-use, accuracy of sampling, and patient comfort level.These measurements will be recorded via a survey for the patient and provider following the procedure.

Вмешательства

  • Устройство Bouquet Speculum
    Novel Bouquet Speculum used for endometrial biopsies

Первичные конечные точки

  • Provider visualization of the cervix, ease of use, and accuracy of a new vaginal speculum being used for endometrial biopsies [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Biological women with a uterus, age 18-90
  • Previous endometrial biopsy procedure performed at the Minnesota Oncology Clinic

Критерии исключения

  • Pregnant women, active pelvic infection, or uncontrolled bleeding dyscrasias as determined by the provider at Minnesota Oncology Clinics
  • Biological women without a uterus who are less than 18 years old or greater than 90 years old, or who have not had a previous endometrial biopsy at the Minnesota Oncology Clinic.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • Rocky Vista Health Clinic — Englewood

Публикации

  • Luzarraga Aznar A, Canton R, Loren G, Carvajal J, de la Calle I, Masferrer-Ferragutcasas C, Serra F, Bebia V, Bonaldo G, Angeles MA, Cabrera S, Palomar N, Vilarmau C, Marti M, Rigau M, Colas E, Gil-Moreno A. Current challenges and emerging tools in endometrial cancer diagnosis. Int J Gynecol Cancer. 2025 Apr;35(4):100056. doi: 10.1016/j.ijgc.2024.100056. Epub 2024 Dec 18. PMID 40011116
  • Amant F, Moerman P, Neven P, Timmerman D, Van Limbergen E, Vergote I. Endometrial cancer. Lancet. 2005 Aug 6-12;366(9484):491-505. doi: 10.1016/S0140-6736(05)67063-8. PMID 16084259
  • Khan S, Waters-Kellar L, Barsh E, Shannon A, Clark S, Ryznar RJ, Trawick A, Payton M, Bouquet J. A Survey of Physicians and Patients in Pakistan Assessing the Improvement of Visualization of the Cervix, Ease of Use, and Patient Comfort Using a Newly Designed Vaginal Speculum: A Pilot Study. Med Devices (Auckl). 2025 Jun 11;18:309-317. doi: 10.2147/MDER.S509134. eCollection 2025. PMID 40599808
  • Bouquet JM, Morris E, Zapata I. A novel and cost-effective model to screen and treat cervical cancer and precancers at the point of care. Front Public Health. 2025 Apr 16;13:1527172. doi: 10.3389/fpubh.2025.1527172. eCollection 2025. PMID 40308928
  • Bouquet JM, Naji R, Armas CA, Roldan V, Selkhi S, Bentley CZ, Zapata I, Fisher J. An Innovative Design for the Vaginal Speculum. Med Devices (Auckl). 2023 Sep 25;16:211-218. doi: 10.2147/MDER.S415558. eCollection 2023. PMID 37790696

Идентификаторы

NCT: NCT07217353 · 2025-158

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗