NCT07398027Not yet recruiting
Post-Market Study of Transbronchial Cryo-assisted RFA During Robotic Bronchoscopy With Subsequent Surgical Resection
Post-Market Study of Transbronchial Cryo-assisted RFA During Robotic Assisted Bronchoscopy With Subsequent Surgical Resection (CRONOS-CH)
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- Mar 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Carolin Steinack
- Diseases
- Lung cancer
- NCT number
- NCT07398027
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Mar 2026 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Thoracic electronic implants (e.g., pacemakers, ICDs)
- Patients receiving anticoagulant therapy or with pulmonary hypertension that, in the opinion of the Investigator, poses an unacceptable safety risk for bronchoscopy and ablation.
- 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
Other illness
- Active systemic infection
- Tumors associated with atelectasis, obstructive pneumonitis, pleural effusion, or fibrosis
Lab values
- Uncorrectable coagulopathy or platelet count ≤ 50,000/mm³
Other
- Pregnant or nursing (breast feeding) females
- Central tumors abutting vital structures (main bronchus, pulmonary artery, esophagus, trachea)
- Severe, uncontrolled comorbidities
- 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
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.