Post-Market Study of Transbronchial Cryo-assisted RFA During Robotic Bronchoscopy With Subsequent Surgical Resection (CRONOS-CH)

Post-Market Study of Transbronchial Cryo-assisted RFA During Robotic Assisted Bronchoscopy With Subsequent Surgical Resection (CRONOS-CH)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: HybridTherm® System

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.

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

Contacts and Locations

• Study Contact: Name: Dr. Carolin Steinack, Head of Interventional Pulmonology; Phone Number: +41 76 771 37 79; Email: carolin.steinack@usz.ch
• Study Contact Backup: Name: Thomas Gaisl, MD; Phone Number: +41 76 771 37 79; Email: thomas.gaisl@usz.ch

Study Locations

• Switzerland
  • Raemistrasse
    • Zurich, Raemistrasse, Switzerland, 8091
      • University Hospital Zurich
      • Contact: Dr. Carolin Steinack, Head of Interventional Pulmonology; Email: carolin.steinack@usz.ch

Participation Criteria

Eligibility Criteria

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

Description

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

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: HybridTherm Cryo-Assisted RFA & surgical resection; Participants undergo transbronchial cryo-assisted radiofrequency ablation (RFA) using the CE-marked HybridTherm® system during routine diagnostic bronchoscopy. When clinically indicated, mediastinal lymph node staging by performed. Surgical resection of the treated lung lesion follows according to the standard clinical treatment plan.

Device: HybridTherm® 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Successful Completion of Bronchoscopic Cryo-assisted RFA Using the HybridTherm® System	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	Day 0 (Diagnostic Bronchoscopy and RFA Procedure)
Number of Participants with Bleeding-Related Serious Adverse Events Associated with the Investigational Device and/or RFA Procedure	Number of Serious Adverse Events (SAEs) associated with bleeding related to the investigational device and/or radiofrequency ablation (RFA) procedure.	From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Severity of Bleeding-Related Adverse Events as Assessed by the Nashville Bleeding Scale	Safety assessments for bleeding Adverse Events (AEs) related to the investigational device and/or radiofrequency ablation (RFA) procedure, graded using the Nashville bleeding scale.	From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Serious Adverse Events Related to the Investigational Device and/or RFA Procedure	Total number of Serious Adverse Events (SAEs) related to the investigational device and/or radiofrequency ablation (RFA) procedure.	From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Total Number of Adverse Events Related to the Investigational Device and/or RFA Procedure	Total number of Adverse Events (AEs) related to the investigational device and/or radiofrequency ablation (RFA) procedure.	From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Macroscopic and Microscopic Evidence of Ablation in the Resected Specimen	Macroscopic and microscopic evidence of ablation in the resected specimen, assessed using standard histopathological methods (hematoxylin and eosin staining).	At Surgical Resection (7-14 Days Post-Procedure)
Percentage of Tumor Necrosis Within the Ablation Zone	Visual estimation of histopathologic ablation completeness, defined as the percentage of tumor necrosis within the ablation zone, as determined by routine pathology reporting.	At Surgical Resection (7-14 Days Post-Procedure)
Histopathologic Complete Response (Absence of Viable Tumor Cells) Within the Ablation Zone	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.	At Surgical Resection (7-14 Days Post-Procedure)
Composite Descriptive Intra-Procedural Metrics During Bronchoscopic Cryo-assisted RFA	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.	Day 0 (Diagnostic Bronchoscopy and RFA Procedure)

Collaborators and Investigators

• Sponsor: Carolin Steinack
• Collaborators: Erbe Elektromedizin GmbH

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 639001022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to local data protection requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No