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

NCT07398027 | Not Yet Recruiting

• 1 other identifier: 639001022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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 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)

• Macroscopic and Microscopic Evidence of Ablation in the Resected Specimen

  At Surgical Resection (7-14 Days Post-Procedure)

• Percentage of Tumor Necrosis Within the Ablation Zone

  At Surgical Resection (7-14 Days Post-Procedure)

• Histopathologic Complete Response (Absence of Viable Tumor Cells) Within the Ablation Zone

  At Surgical Resection (7-14 Days Post-Procedure)

Study Arms (1)

HybridTherm Cryo-Assisted RFA & surgical resection

EXPERIMENTAL

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

Interventions

HybridTherm® System DEVICE

Transbronchial cryo-assisted radiofrequency ablation (RFA) performed using the CE-marked HybridTherm® system during routine diagnostic bronchoscopy, within the intended use of the device.

HybridTherm Cryo-Assisted RFA & surgical resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Carolin Steinack: lead
• Erbe Elektromedizin GmbH: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Raemistrasse, 8091, Switzerland

Location

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MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Dr. Carolin Steinack, Head of Interventional Pulmonology

CONTACT

+41 76 771 37 79; carolin.steinack@usz.ch

Thomas Gaisl, MD

CONTACT

+41 76 771 37 79; thomas.gaisl@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Interventional Pulmonology, Sponsor, Principal Investigator

Model Details: Prospective, single-arm clinical investigation conducted at a single site.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)