NCT07398027Not yet recruiting
Post-Market Study of Transbronchial Cryo-assisted RFA During Robotic Bronchoscopy With Subsequent Surgical Resection
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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Not yet recruiting
- Phase
- No phase (N/A)
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- Carolin Steinack(Other)
- Protocol no.
- 639001022
- Conditions
- Lung Cancer
- Interventions
- Device
Treatments studied
- HybridTherm® System
Collaborators
Erbe Elektromedizin GmbH
Locations · 1
- Zurich, SwitzerlandUniversity Hospital ZurichNot yet recruiting at this site
In total, worldwide, the only site listed in the registry is planned; recruitment has not opened yet.
Site status per the ClinicalTrials.gov registry (last update posted: February 9, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.