Post-Market Registry of Transbronchial Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Stagng and Resection

Обзор

In order to secure the diagnosis of lung cancer, the investigator will perform a bronchoscopy in order to take tissue samples. These samples will be analyzed in the pathology. This is the routine standard. The aim of the study is to treat the lesion with a device that works both with cold and radiofrequency. The device is already in use for the treatment of lesions. The device allows direct treatment of the lesion during the routine bronchoscopy. As planned, the lesion will then be surgically removed. After the surgery the lesion will be analyzed in the pathology to show the effect of the use of the device. This additional treatment is safe and will support the treatment of the lesion. There are no additional steps or assessments for the participants to undergo.

Вмешательства

• Устройство Cryotherapy
  Transbronchiual Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Staging and Resection

Первичные конечные точки

• Successful device use, defined as the completion of ablation with the HybridTherm® system with investigator confirmation that the ablation zone achieved sufficient coverage based on intra-procedural imaging. [Срок оценки: during procedure]

Вторичные конечные точки (6)

• Safety outcomes, with a specific focus on bleeding events, graded according to the Nashville Bleeding Scale, and the occurrence of other adverse events as documented in the medical record. [Срок оценки: up to 6 - 7 weeks post procedure]
• Macroscopic and microscopic evidence of ablation in the resected specimen, assessed using standard histopathological methods (H&E staining). [Срок оценки: within 24 hours after procedure]
• Visual estimation of histopathologic ablation completeness, defined as the estimated percentage of tumor necrosis within the ablation zone, as determined by routine pathology reporting. [Срок оценки: within 24 hours after procedure]
• Evaluation of macroscopic and microscopic necrosis within the ablation zone (histopathologic complete response hpCR), defined as the absence of viable tumor cells within the ablated area, if reported as part of routine histological assessment. [Срок оценки: within24 hours after procedure]
• Descriptive intra-procedural metrics, recorded during the bronchoscopy procedure: Total ablation time; Number of cryoRFA activations; Electrical parameters of energy delivered during the procedure; Number of probe repositioning within the lesion [Срок оценки: day 0]
• Estimated ablation zone size (mm), derived from intraoperative CBCT, routinely obtained during the procedure. [Срок оценки: day 0]

Критерии участия

Критерии включения

• Solitary nodule ≤ 2.5 cm
• Candidate for diagnostic bronchoscopy \& LN staging
• Eligible for surgical resection
• Histologically proven lung cancer
• ≥20 mm margin to pleura/vessels/bronchi
• Signed informed consent, age ≥18 y.

Критерии исключения

• Pregnancy/nursing
• central tumours abutting vital structures
• thoracic electronic implants
• uncorrectable coagulopathy or platelets ≤50 × 10⁹/L
• severe uncontrolled comorbidities or infection; prior SBRT to zone
• recent investigational therapy (<30 d)
• atelectasis/obstructive pneumonitis/effusion/fibrosis
• investigator-determined risk.

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

Австрия · 1 центр

• Ordensklinikum Linz Elisabethinen — Linz

Идентификаторы

NCT: NCT07530744 · 639001021 · 1298/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗