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

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 Overview

• Status: Not yet recruiting
• Conditions: NSCLC; Cryotherapy; RFA
• Intervention / Treatment: Device: Cryotherapy

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adrienne Seil; Phone Number: 0043 732 7676 4492; Email: adrienne.seil@ordensklinikum.at
• Study Contact Backup: Name: Julia Dort; Phone Number: 0043 732 7676 4648; Email: juliabianca.dort@ordensklinikum.at

Study Locations

• Austria
  • Linz, Austria
    • Ordensklinikum Linz Elisabethinen
    • Principal Investigator: Christopher Lambers
    • Contact: Adrienne Seil; Phone Number: 0043 732 7676 4492; Email: adrienne.seil@ordensklinikum.at
    • Contact: Julia Dort; Phone Number: 0043 732 7676 4648; Email: juliabianca.dort@ordensklinikum.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryo-assisted RFA during Routine Standard Bronchoscopic Tumor Staging and Resection	Device: Cryotherapy; Transbronchiual Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Staging and Resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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; Suctioning of blood required for less than 1 minute Minimal bleeding of no clinical consequence to the patient or the provider; Suctioning more than 1 minute, or repeat wedging of the bronchoscope for persistent bleeding, or instillation of cold saline, diluted vasoactive agents, or thrombin Requires tools to control or prevent further bleeding; Selective intubation with endotracheal tube (ETT) or balloon/bronchial blocker for < 20 minutes, or premature interruption of the procedure Short-term but clinically meaningful change requiring more invasive intervention and procedure interruption; Persistent selective intubation > 20 minutes, or ICU admission, or PRBC transfusion, or need for bronchial artery embolization or resuscitation Indicates serious deterioration, requiring escalation of care and advanced ventilatory and hemodynamic support	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

Collaborators and Investigators

• Sponsor: Elisabethinen Hospital
• Investigators: Principal Investigator: Christopher Lambers, Elisabethinen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Tumor Staging and Resection
• Additional Relevant MeSH Terms: Therapeutics; Cryotherapy
• Other Study ID Numbers: 639001021; 1298/2025 (Other Identifier: Ethics Committee JKU Linz)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: to be determined by Principal Investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No