Post-Market Registry of Transbronchial Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Stagng and Resection
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Elisabethinen Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Cryo-assisted RFA during Routine Standard Bronchoscopic Tumor Staging and Resection
Intervention: Cryotherapy (Device)
Outcomes
Primary Outcomes
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.
Time Frame: during procedure
Secondary Outcomes
- 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)
Investigators
Christopher Lambers
Priv.Doz.Dr
Elisabethinen Hospital