Post-Market Registry of Transbronchial Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Stagng and Resection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cryo-assisted RFA during Routine Standard Bronchoscopic Tumor Staging and Resection
干预措施: Cryotherapy (Device)
结局指标
主要结局
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.
时间窗: during procedure
次要结局
- 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.(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).(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.(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.(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(day 0)
- Estimated ablation zone size (mm), derived from intraoperative CBCT, routinely obtained during the procedure.(day 0)
研究者
Christopher Lambers
Priv.Doz.Dr
Elisabethinen Hospital