Меню
Идёт набор NCT06423690

First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System

Без фазы С лечением Lung 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: EAS1 System.
Кому может быть актуально
Состояния в реестре: Lung Cancer. Базовые параметры: 18 лет — 80 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
Израиль, Испания, Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Snipe Medical First In Human Study

Обзор

A Prospective, open label, multi center, single arm, First in Human study to assess the safety and initial performance of EAS1 system for Irreversible Electroporation (IRE) ablation of lung cancer in subjects eligible for tumor resection

Вмешательства

  • Устройство EAS1 System
    tumor ablation system in IRE method

Первичные конечные точки

  • Safety of the EAS1 System in Lung Tumor Ablation During Procedure [Срок оценки: 48 hours post procedure]
Вторичные конечные точки (2)
  • Safety of the EAS1 System in Lung Tumor Ablation Throughout Follow Up [Срок оценки: 30 days]
  • Investigator's Ability to Approach and Ablate the Tumor (Technical Success) [Срок оценки: 30 days]

Критерии участия

Критерии включения

  • Adult male and female subjects (age ≥18 years at the date of informed consent signature)
  • Subject is capable and willing to provide an informed consent
  • Subjects with a known diagnosis of lung cancer at cT1a-T1c, cN0 stages
  • At least one pulmonary tumor (primary or metastasis) ≤ 30 mm in maximal diameter, as confirmed by the latest standard of care imaging (CT/MRI), performed preferably up to 30 days prior to screening
  • Subjects who are scheduled or deemed eligible by a thoracic surgeon for lung tumor resection
  • Subject is able and willing to comply with the study procedures and visits
  • There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure, as confirmed by the latest standard of care imaging (CT/MRI), performed preferably up to 30 days prior to screening
  • ECOG 0-1
  • Stable doses of concomitant medications for at least four (4) weeks prior to enrollment

Критерии исключения

  • An inability to provide informed consent
  • Subjects with contraindication for tumor resection
  • Subjects with life expectancy <12 months
  • Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea
  • Subjects with Forced Expiratory Volume (FEV1) <50%
  • Total Lung Capacity (TLC)< 80% of expected for age
  • Diffusing Capacity (DCO) < 60% of expected
  • Oxygen saturation in free air of <88%, or requiring more than 2 l/min oxygen to achieve saturation of 92%
  • PCO2 of ≥ 45mm/Hg
  • Subjects in exacerbations group E (high risk; ≥2 exacerbations per year or ≥1 requiring hospitalization and any level of symptoms)
  • Severe emphysema, Bullous Emphysema or chronic obstructive pulmonary disease (COPD) (GOLD III/IV)
  • Active and/or prolonged lung or bronchi infection, required an antibiotic treatment up to 21 days prior to screening and for more than 10 days of treatment
  • Known history or current evidence of a significant bronchiectasis
  • Evidence of lung Bullae the occupies more than one third of the lung intended for ablation
  • Previous surgery in the lung intended for ablation; thoracic major surgery at the side intended for ablation
  • Anticoagulation treatment that cannot be discontinued prior to the ablation, or a bleeding diathesis or platelets <100 )K/µl)
  • Pregnant or breastfeeding female subjects or female subjects who plan pregnancy during participation in the study
  • Highly hypoxemic patients, according to investigator's discretion
  • Subjects with implanted metal or electronic thoracic devices objects (such as pacemaker) that cannot be removed prior to procedure
  • Subjects with contraindication for bronchoscopy
  • Participation in any other interventional clinical trial with medication, medical device and/or supplements within 30 days prior to informed consent signature
  • Any subject who, at the discretion of the investigator, may be jeopardized by study participation

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
Лечение

Центры проведения

Израиль · 1 центр
  • Meir Medical Center — Kfar Saba
Испания · 1 центр
  • University Hospital Complex of Salamanca — Salamanca
Великобритания · 1 центр
  • Royal Brompton Hospital — London

Идентификаторы

NCT: NCT06423690 · PRC015

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗