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| ID | Type | Description | Link |
|---|---|---|---|
| 1298/2025 | Other Identifier | Ethics Committee JKU Linz |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryo-assisted RFA during Routine Standard Bronchoscopic Tumor Staging and Resection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy | Device | Transbronchiual Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Staging and Resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Nashville Bleeding Scale Grade Findings at Bronchoscopy Rationale
|
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Inclusion Criteria:
Exclusion Criteria:
pregnant or breastfeeding women are to be excluded
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrienne Seil | Contact | 0043 732 7676 4492 | adrienne.seil@ordensklinikum.at | |
| Julia Dort | Contact | 0043 732 7676 4648 | juliabianca.dort@ordensklinikum.at |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Lambers | Elisabethinen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordensklinikum Linz Elisabethinen | Linz | Austria |
to be determined by Principal Investigator
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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 | total ablation time will be recorded in minutes; number of cryoRFA activations will be recorded in energy applications; | day 0 |
| Estimated ablation zone size (mm), derived from intraoperative CBCT, routinely obtained during the procedure. | day 0 |