Establishing Feasibility of Transbronchial Cryoablation With an In-Development Cryoprobe: An Ex-Vivo Human Lung Model

Обзор

Demonstrate the application of in-development cryogenic catheters for the ablation of pulmonary lesions.

Подробное описание

Surgical resection is the current gold standard for curative treatment of pulmonary lesions. For patients ineligible for surgical resection, transthoracic percutaneous ablation is sometimes used. Albeit the use of minimally techniques for both surgery and ablation, these interventions are associated with a high risk of complication. To reduce associated risks, transbronchial interventions have been proposed as promising alternatives. However, currently available transbronchial ablation technologies may present significant risks of bleeding or lack clinical evidence with regards to efficacy. When considering potential alternatives, promising results have been achieved using cryotechnology for cryoablation. However, the feasibility of a transbronchial cryoablation device and its thermal performance at varying freeze-thaw cycles in a clinical setting is unknown. The investigators aim to demonstrate the application of in-development transbronchial cryogenic catheters for the ablation of pulmonary lesions.

The investigators aim to confirm the design and operating specifications of an in-development cryogenic catheters for the ablation of pulmonary lesions and investigate the thermal performance of the catheter.

Вмешательства

• Устройство Ex vivo cryo-ablation
  With informed consent obtained prior to transplantation, explanted lungs from patients undergoing lung transplantation will be obtained. The organs will be placed in an acrylic box and will be perfused at a temperature of 37 Celsius degrees. The lungs will be mechanically ventilated connected by an endotracheal tube size 7 inserted in the bronchus with the balloon inflated and a silk suture providing a hermetic closure proximal to the balloon. The cryocatheter will be inserted in the lungs and c

Первичные конечные точки

• Tissue temperature at 5 mm from the probe over intervention time [Срок оценки: 48 months]
• Tissue temperature at 10 mm from the probe over intervention time [Срок оценки: 48 months]
• Tissue temperature at 15 mm from the probe over intervention time [Срок оценки: 48 Months]

Вторичные конечные точки (1)

• Iceball size [Срок оценки: 48 months]

Критерии участия

Критерии включения

Patients undergoing lung transplant surgery

Критерии исключения

Organ donors eligible to donate lungs for transplantation Healthy individuals Patients with ongoing pulmonary infection at the time of transplant

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

Оценка устройства

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07104253 · 2025-12805

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗