NSCLCCronosNCT07530744
Post-Market Registry of Transbronchial Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Stagng and Resection
A study testing Cryotherapy in people with NSCLC and Cryotherapy, run by Elisabethinen Hospital at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NSCLC, Cryotherapy, RFA
- What is being tested?
- Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- May 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Ordensklinikum Linz Elisabethinen
Linz
Adrienne Seil, 0043 732 7676 4492, adrienne.seil@ordensklinikum.at
Julia Dort, 0043 732 7676 4648, juliabianca.dort@ordensklinikum.at
About this study
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
- NSCLC, Cryotherapy, RFA
- Being tested
- Cryotherapy
- Keywords
- Tumor Staging and Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyDevice
Transbronchiual Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Staging and Resection
| Study group | Role | What they receive |
|---|---|---|
| Cryo-assisted RFA during Routine Standard Bronchoscopic Tumor Staging and Resection | Experimental | Not described Receives: Device: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during procedure
Secondary outcomes (6)
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.
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
Measured: up to 6 - 7 weeks post procedure
Macroscopic and microscopic evidence of ablation in the resected specimen, assessed using standard histopathological methods (H&E staining).
Measured: within 24 hours after procedure
Visual estimation of histopathologic ablation completeness, defined as the estimated percentage of tumor necrosis within the ablation zone, as determined by routine pathology reporting.
Measured: within 24 hours after procedure
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.
Measured: within24 hours after procedure
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
total ablation time will be recorded in minutes; number of cryoRFA activations will be recorded in energy applications;
Measured: day 0
Estimated ablation zone size (mm), derived from intraoperative CBCT, routinely obtained during the procedure.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elisabethinen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Lambers, Elisabethinen Hospital
- Investigators
- Christopher Lambers, Principal investigator, Elisabethinen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530744
- Sponsor's protocol ID
- 639001021
- Other IDs
- 1298/2025
- Acronym
- Cronos
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: to be determined by Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Registry of Transbronchial Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Stagng and Resection
- ClinicalTrials.gov ID
- NCT07530744
- Acronym / sponsor ID
- Cronos / 639001021
- Conditions
- NSCLC, Cryotherapy, RFA
- Keywords
- Tumor Staging and Resection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Elisabethinen HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryo-assisted RFA during Routine Standard Bronchoscopic Tumor Staging and Resection | Experimental | Device: Cryotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryotherapyTransbronchiual Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Staging and Resection | Device | Cryo-assisted RFA during Routine Standard Bronchoscopic Tumor Staging and Resection |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
Estimated ablation zone size (mm), derived from intraoperative CBCT, routinely obtained during the procedure.
Time frame: day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided. to be determined by Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Lambers principal investigator
Elisabethinen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with NSCLC and Cryotherapy, run by Elisabethinen Hospital at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrienne Seil (0043 732 7676 4492, adrienne.seil@ordensklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.