Lung Cancer
Conditions
Brief summary
The purpose of this study is to confirm the procedural feasibility and device usability of the HybridTherm® system during bronchoscopic cryo-assisted radiofrequency ablation (RFA) performed prior to scheduled surgical resection in patients with lung cancer. The bronchoscopy session includes tumor ablation and, when clinically indicated, mediastinal lymph node staging by EBUS-TBNA.
Detailed description
This is a prospective, single-arm, post-market clinical investigation conducted in Switzerland to collect clinical data on the use, safety, and performance of the CE-marked HybridTherm® system during routine bronchoscopic tumor management procedures. The investigation is classified as a ClinO-MD Category A1 medical device study, as the HybridTherm® system is CE-marked and used strictly within its intended purpose under normal conditions of clinical use. The investigation is investigator-initiated and single-center, conducted at the University Hospital Zurich. The Sponsor-Investigator is responsible for the initiation, conduct, management, safety oversight, and data handling of the study in accordance with the Swiss Human Research Act (HRA), the Ordinance on Clinical Trials with Medical Devices (ClinO-MD), ISO 14155, and applicable ethical requirements. Ethics Committee approval is required prior to study initiation, and the investigation will begin only after a positive written decision from the competent cantonal ethics committee has been obtained. The HybridTherm® system is a bipolar cryo-cooled radiofrequency ablation device intended for incision, coagulation, and ablation of tissue during flexible endoscopic procedures in the tracheobronchial system. The system provides internally cooled radiofrequency energy to delay tissue desiccation and impedance rise, thereby enabling controlled energy delivery during ablation. In this investigation, the device is used during clinically indicated bronchoscopic procedures without deviation from its approved indication or standard clinical workflow. All enrolled participants undergo diagnostic bronchoscopy as part of routine clinical care, including mediastinal lymph node staging when clinically indicated. Transbronchial cryo-assisted radiofrequency ablation is performed during the same bronchoscopy session under general anesthesia. Surgical resection of the targeted lung lesion follows according to the established oncologic treatment plan and is not altered by study participation. No randomization, blinding, or comparator intervention is included. Data collected in this investigation are derived exclusively from standard-of-care procedures, routine imaging, device readouts, and histopathological assessment of resected specimens. No additional diagnostic tests, therapeutic interventions, or protocol-mandated procedures beyond routine clinical practice are introduced. All analyses are descriptive in nature and are intended to support post-market evaluation of procedural feasibility, safety, and device usability. The investigation is designed to generate clinical experience and safety data that may inform future clinical research and support the continued evaluation of bronchoscopic cryo-assisted radiofrequency ablation using the HybridTherm® system within standard treatment pathways.
Interventions
DEVICEHybridTherm® System
Transbronchial cryo-assisted radiofrequency ablation (RFA) performed using the CE-marked HybridTherm® system during routine diagnostic bronchoscopy, within the intended use of the device.
Sponsors
Carolin Steinack
Erbe Elektromedizin GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single-arm clinical investigation conducted at a single site.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who require diagnostic bronchoscopy for suspicious lung lesions with mediastinal lymph node status confirmed as NO by one of the following: Prior PET-CT showing no FDG-avid mediastinal lymph nodes, OR intraoperative EBUS-TBNA with ROSE confirming negative lymph nodes (performed when clinically indicated per section 6.1). * Solitary pulmonary lesions ≤ 2.5cm with histologically or cytologically confirmed primary lung cancer. * Suitable candidate for surgical resection of the tumor targeted for ablation * Interdisciplinary tumor board consent * Ability to read, understand, and sign patient Informed Consent Form (ICF) * Age ≥ 18-years-old * ≥ 20 mm of free space between the calculated intended ablation zone and the lung parenchyma or any critical structures (pleura, vessels and main bronchi).
Exclusion criteria
* Pregnant or nursing (breast feeding) females * Central tumors abutting vital structures (main bronchus, pulmonary artery, esophagus, trachea) * Thoracic electronic implants (e.g., pacemakers, ICDs) * Uncorrectable coagulopathy or platelet count ≤ 50,000/mm³ * Patients receiving anticoagulant therapy or with pulmonary hypertension that, in the opinion of the Investigator, poses an unacceptable safety risk for bronchoscopy and ablation. * Severe, uncontrolled comorbidities * Active systemic infection * Prior radiation therapy (SBRT) in the intended ablation zone * Recent Investigational therapy within the last 30 days that the investigator deems could interfere with proceeding in the clinical investigation * Tumors associated with atelectasis, obstructive pneumonitis, pleural effusion, or fibrosis * Investigators determine that study participation poses safety risk * Any comorbidities judged by the principal Investigator to be contraindicated for bronchoscopy * Subject was judged unsuitable for study participation by the Investigator for any other reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Successful Completion of Bronchoscopic Cryo-assisted RFA Using the HybridTherm® System | Day 0 (Diagnostic Bronchoscopy and RFA Procedure) | 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 |
| Number of Participants with Bleeding-Related Serious Adverse Events Associated with the Investigational Device and/or RFA Procedure | From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure) | Number of Serious Adverse Events (SAEs) associated with bleeding related to the investigational device and/or radiofrequency ablation (RFA) procedure. |
| Severity of Bleeding-Related Adverse Events as Assessed by the Nashville Bleeding Scale | From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure) | Safety assessments for bleeding Adverse Events (AEs) related to the investigational device and/or radiofrequency ablation (RFA) procedure, graded using the Nashville bleeding scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Serious Adverse Events Related to the Investigational Device and/or RFA Procedure | From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure) | Total number of Serious Adverse Events (SAEs) related to the investigational device and/or radiofrequency ablation (RFA) procedure. |
| Total Number of Adverse Events Related to the Investigational Device and/or RFA Procedure | From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure) | Total number of Adverse Events (AEs) related to the investigational device and/or radiofrequency ablation (RFA) procedure. |
| Macroscopic and Microscopic Evidence of Ablation in the Resected Specimen | At Surgical Resection (7-14 Days Post-Procedure) | Macroscopic and microscopic evidence of ablation in the resected specimen, assessed using standard histopathological methods (hematoxylin and eosin staining). |
| Percentage of Tumor Necrosis Within the Ablation Zone | At Surgical Resection (7-14 Days Post-Procedure) | Visual estimation of histopathologic ablation completeness, defined as the percentage of tumor necrosis within the ablation zone, as determined by routine pathology reporting. |
| Histopathologic Complete Response (Absence of Viable Tumor Cells) Within the Ablation Zone | At Surgical Resection (7-14 Days Post-Procedure) | Evaluation of macroscopic and microscopic necrosis within the ablation zone, defined as the absence of viable tumor cells within the ablated area (histopathologic complete response, hpCR), if reported as part of routine histological assessment. If applicable, the extent of necrosis into surrounding parenchyma or margin tissue will be noted. |
| Composite Descriptive Intra-Procedural Metrics During Bronchoscopic Cryo-assisted RFA | Day 0 (Diagnostic Bronchoscopy and RFA Procedure) | Descriptive intra-procedural metrics collected during the bronchoscopic cryo-assisted radiofrequency ablation (RFA) procedure, including total ablation time (minutes), number of cryoRFA activations (energy applications), electrical parameters of energy delivered (if available), number of probe repositionings within the lesion, and estimated ablation zone size (millimeters) derived from intraoperative imaging when obtained as part of routine clinical practice. These measures are collected for descriptive characterization of procedural performance and are not intended for separate outcome analysis. |
Countries
Switzerland
Contacts
CONTACTDr. Carolin Steinack, Head of Interventional Pulmonology
CONTACTThomas Gaisl, MD
Outcome results
None listed