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Набор по приглашению NCT07046832

Clinical Evaluation of an Augmented Reality Intraprocedural Needle Guidance Platform for Soft Tissue Biopsy

Без фазы С лечением Oncology Interventional Radiology Liver Carcinoma Renal Carcinoma

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: Augmented Reality Guided Biopsy, Ultrasound Guided Biopsy.
Кому может быть актуально
Состояния в реестре: Oncology, Interventional Radiology, Liver Carcinoma, Renal Carcinoma. Базовые параметры: от 18 лет · Все.
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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Официальное название

Clinical Evaluation of an Intra-procedural 3D Needle Guidance Platform for Soft Tissue Tumors or Organs Requiring Percutaneous Biopsy as an Adjunct to Standard Image Guidance

Обзор

This clinical feasibility evaluation is intended to further characterize and quantify the potential benefits of the FDA-cleared XR90 Augmented Reality (AR )imaging and guidance platform utilization in percutaneous soft tissue biopsy. This study will seek to build on the findings of safety, procedural benefits, and overall clinical feasibility shown in previous bench, cadaveric, and single-site clinical evaluations.

Подробное описание

This clinical evaluation is needed to further characterize and quantify the potential benefits of percutaneous biopsy, assisted with the XR90 3D surgical imaging system. This continued innovative implementation of the platform as a medical device to assist in percutaneous targeted biopsy of soft tissue tumors will allow for further assessment of device functionality, operator acceptability, and additional data collection to help quantify the potential benefits of this platform. Potential benefits to the patient, to be formally proven in future studies: decreased procedure time, decreased of complications (e.g., critical structure avoidance), and ultimately, improved patient outcomes. To date, few studies have evaluated the performance of the XR90 guidance system in a clinical setting. Comparing percutaneous needle placement for biopsies of a soft tissue target with the assistance of XR90 compared to under only standard-of-care guidance will allow for the evaluation of procedure success rate, overall procedure time, and complications. This multicenter prospective randomized control trial is designed to compare the efficacy and utility of the XR90 guidance platform used adjunct to standard of care guidance to standard of care guidance (2D) only for percutaneous needle-based procedures.

Вмешательства

  • Устройство Augmented Reality Guided Biopsy
    Augmented Reality system in adjunct to standard of care guidance for needle guidance during a percutaneous biopsy
  • Устройство Ultrasound Guided Biopsy
    Ultrasound guided biopsy as a part of standard of care.

Первичные конечные точки

  • Time of Tumor Localization [Срок оценки: Intraprocedural-from the start of the procedure until the end of the study procedure, 1 day.]
  • Time From Skin to Target [Срок оценки: Intraprocedural, from the start of the procedure until the end of the study procedure, 1 day.]
Вторичные конечные точки (2)
  • Technical Success [Срок оценки: Duration of the study procedure]
  • Needle Attempts [Срок оценки: Duration of the study procedure]

Критерии участия

Критерии включения

  • At least 18 years of age
  • Willing and able to give informed consent prior to enrollment
  • Subjects in need of a diagnostic soft-tissue tumor biopsy which is the primary target for needle placement as a part of their standard of care.
  • Subjects who have met all criteria to undergo percutaneous biopsy with ultrasound.
  • Subjects with soft-tissue lesions ≥1 cm or ≤8 cm in depth
  • BMI of ≤40

Критерии исключения

  • Children under the age of 18.
  • Currently pregnant at the time of the procedure
  • Not willing or able to give informed consent.
  • Subjects with pacemakers or AICDs.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Диагностика

Центры проведения

США · 3 центра
  • MedStar Georgetown Hospital — Washington D.C.
  • MedStar Washington Hosptial Center — Washington D.C.
  • NewYork-Presbyterian Weill Cornell Medical Center — New York

Публикации

  • Al-Nimer S, Hanlon A, Cho K, Kalra-Lall A, Weunski C, Yanof J, West K, Martin C 3rd. 3D Holographic Guidance and Navigation for Percutaneous Ablation of Solid Tumor. J Vasc Interv Radiol. 2020 Mar;31(3):526-528. doi: 10.1016/j.jvir.2019.09.027. Epub 2020 Jan 31. No abstract available. PMID 32008844
  • Gadodia G, Yanof J, Hanlon A, Bustos S, Weunski C, West K, Martin C 3rd. Early Clinical Feasibility Evaluation of an Augmented Reality Platform for Guidance and Navigation during Percutaneous Tumor Ablation. J Vasc Interv Radiol. 2022 Mar;33(3):333-338. doi: 10.1016/j.jvir.2021.11.014. PMID 35221048

Идентификаторы

NCT: NCT07046832 · 24-06-433

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗