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

Starting soon · Not applicable

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT07398027

Run by

Carolin Steinack

People needed

20

Starts

2026-03-01

Expected to finish

2027-09-01

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University Hospital Zurich — Zurich, Raemistrasse, Switzerland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.