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NCT Number: NCT07530744

Post-Market Registry of Transbronchial Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Stagng and Resection

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.

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Key information

Conditions

NSCLC Cryotherapy RFA

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cryotherapy

Device

Transbronchiual Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Staging and Resection

Primary outcomes

  1. 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.

    Time frame: during procedure

Secondary outcomes

  1. 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.

    Time frame: up to 6 - 7 weeks post procedure

    Nashville Bleeding Scale Grade Findings at Bronchoscopy Rationale

    • Suctioning of blood required for less than 1 minute Minimal bleeding of no clinical consequence to the patient or the provider
    • 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
    • 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
    • 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

  2. Macroscopic and microscopic evidence of ablation in the resected specimen, assessed using standard histopathological methods (H&E staining).

    Time frame: within 24 hours after procedure

  3. Visual estimation of histopathologic ablation completeness, defined as the estimated percentage of tumor necrosis within the ablation zone, as determined by routine pathology reporting.

    Time frame: within 24 hours after procedure

  4. Evaluation of macroscopic and microscopic necrosis within the ablation zone (histopathologic complete response hpCR), defined as the absence of viable tumor cells within the ablated area, if reported as part of routine histological assessment.

    Time frame: within24 hours after procedure

  5. Descriptive intra-procedural metrics, recorded during the bronchoscopy procedure: Total ablation time; Number of cryoRFA activations; Electrical parameters of energy delivered during the procedure; Number of probe repositioning within the lesion

    Time frame: day 0

    total ablation time will be recorded in minutes; number of cryoRFA activations will be recorded in energy applications;

  6. Estimated ablation zone size (mm), derived from intraoperative CBCT, routinely obtained during the procedure.

    Time frame: day 0

Study contacts

Contact information is provided by the study sponsor or research team.

Adrienne Seil

CONTACT

[email protected]

0043 732 7676 4492

Julia Dort

CONTACT

[email protected]

0043 732 7676 4648

Sponsors and collaborators

Lead sponsor

Elisabethinen Hospital

Other

Registry information

Acronym: Cronos

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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