Clinical trial · Interventional
Post-Market Registry of Transbronchial Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Stagng and Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In order to secure the diagnosis of lung cancer, the investigator will perform a bronchoscopy in order to take tissue samples. These samples will be analyzed in the pathology. This is the routine standard. The aim of the study is to treat the lesion with a device that works both with cold and radiofrequency. The device is already in use for the treatment of lesions. The device allows direct treatment of the lesion during the routine bronchoscopy. As planned, the lesion will then be surgically removed. After the surgery the lesion will be analyzed in the pathology to show the effect of the use of the device. This additional treatment is safe and will support the treatment of the lesion. There are no additional steps or assessments for the participants to undergo.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cryotherapy | — | UNRESOLVED | — |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| RFA | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cryo-assisted RFA during Routine Standard Bronchoscopic Tumor Staging and Resection
- interventionNames
- Device: Cryotherapy
Primary outcomes (1)
- measure
- 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.
- timeFrame
- during procedure
Secondary outcomes (6)
- measure
- Safety outcomes, with a specific focus on bleeding events, graded according to the Nashville Bleeding Scale, and the occurrence of other adverse events as documented in the medical record.
- timeFrame
- up to 6 - 7 weeks post procedure
- description
- Nashville Bleeding Scale Grade Findings at Bronchoscopy Rationale 1. Suctioning of blood required for less than 1 minute Minimal bleeding of no clinical consequence to the patient or the provider 2. Suctioning more than 1 minute, or repeat wedging of the bronchoscope for persistent bleeding, or instillation of cold saline, diluted vasoactive agents, or thrombin Requires tools to control or prevent further bleeding 3. Selective intubation with endotracheal tube (ETT) or balloon/bronchial blocker for \< 20 minutes, or premature interruption of the procedure Short-term but clinically meaningful change requiring more invasive intervention and procedure interruption 4. Persistent selective intubation \> 20 minutes, or ICU admission, or PRBC transfusion, or need for bronchial artery embolization or resuscitation Indicates serious deterioration, requiring escalation of care and advanced ventilatory and hemodynamic support
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Solitary nodule ≤ 2.5 cm * Candidate for diagnostic bronchoscopy \& LN staging * Eligible for surgical resection * Histologically proven lung cancer * ≥20 mm margin to pleura/vessels/bronchi * Signed informed consent, age ≥18 y. Exclusion Criteria: * Pregnancy/nursing * central tumours abutting vital structures * thoracic electronic implants * uncorrectable coagulopathy or platelets ≤50 × 10⁹/L * severe uncontrolled comorbidities or infection; prior SBRT to zone * recent investigational therapy (\<30 d) * atelectasis/obstructive pneumonitis/effusion/fibrosis * investigator-determined risk.
References
Publications (0)
Data not yet available