Lung CancerCRONOS-CHNCT07398027
Post-Market Study of Transbronchial Cryo-assisted RFA During Robotic Bronchoscopy With Subsequent Surgical Resection
A study testing HybridTherm® System in people with Lung Cancer, run by Carolin Steinack at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- HybridTherm® System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2026to Sep 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Carolin Steinack, Head of Interventional Pulmonology contact
Switzerland1 site
University Hospital Zurich
Zurich, Raemistrasse, 8091
Dr. Carolin Steinack, Head of Interventional Pulmonology, carolin.steinack@usz.ch
About this study
Official title: Post-Market Study of Transbronchial Cryo-assisted RFA During Robotic Assisted Bronchoscopy With Subsequent Surgical Resection (CRONOS-CH)
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.
Read the detailed description
This is a prospective, single-arm, post-market clinical investigation conducted in Switzerland to collect clinical data on the use, safety, and performance of the CE-marked HybridTherm® system during routine bronchoscopic tumor management procedures. The investigation is classified as a ClinO-MD Category A1 medical device study, as the HybridTherm® system is CE-marked and used strictly within its intended purpose under normal conditions of clinical use.
The investigation is investigator-initiated and single-center, conducted at the University Hospital Zurich. The Sponsor-Investigator is responsible for the initiation, conduct, management, safety oversight, and data handling of the study in accordance with the Swiss Human Research Act (HRA), the Ordinance on Clinical Trials with Medical Devices (ClinO-MD), ISO 14155, and applicable ethical requirements. Ethics Committee approval is required prior to study initiation, and the investigation will begin only after a positive written decision from the competent cantonal ethics committee has been obtained.
The HybridTherm® system is a bipolar cryo-cooled radiofrequency ablation device intended for incision, coagulation, and ablation of tissue during flexible endoscopic procedures in the tracheobronchial system. The system provides internally cooled radiofrequency energy to delay tissue desiccation and impedance rise, thereby enabling controlled energy delivery during ablation. In this investigation, the device is used during clinically indicated bronchoscopic procedures without deviation from its approved indication or standard clinical workflow.
All enrolled participants undergo diagnostic bronchoscopy as part of routine clinical care, including mediastinal lymph node staging when clinically indicated. Transbronchial cryo-assisted radiofrequency ablation is performed during the same bronchoscopy session under general anesthesia. Surgical resection of the targeted lung lesion follows according to the established oncologic treatment plan and is not altered by study participation. No randomization, blinding, or comparator intervention is included.
Data collected in this investigation are derived exclusively from standard-of-care procedures, routine imaging, device readouts, and histopathological assessment of resected specimens. No additional diagnostic tests, therapeutic interventions, or protocol-mandated procedures beyond routine clinical practice are introduced. All analyses are descriptive in nature and are intended to support post-market evaluation of procedural feasibility, safety, and device usability.
The investigation is designed to generate clinical experience and safety data that may inform future clinical research and support the continued evaluation of bronchoscopic cryo-assisted radiofrequency ablation using the HybridTherm® system within standard treatment pathways.
- Conditions
- Lung Cancer
- Being tested
- HybridTherm® System
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HybridTherm® SystemDevice
Transbronchial cryo-assisted radiofrequency ablation (RFA) performed using the CE-marked HybridTherm® system during routine diagnostic bronchoscopy, within the intended use of the device.
| Study group | Role | What they receive |
|---|---|---|
| HybridTherm Cryo-Assisted RFA & surgical resection | Experimental | Participants undergo transbronchial cryo-assisted radiofrequency ablation (RFA) using the CE-marked HybridTherm® system during routine diagnostic bronchoscopy. When clinically indicated, mediastinal lymph node staging by performed. Surgical resection of the treated lung lesion follows according to the standard clinical treatment plan. Receives: Device: HybridTherm® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Successful Completion of Bronchoscopic Cryo-assisted RFA Using the HybridTherm® System
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: Day 0 (Diagnostic Bronchoscopy and RFA Procedure)
Number of Participants with Bleeding-Related Serious Adverse Events Associated with the Investigational Device and/or RFA Procedure
Number of Serious Adverse Events (SAEs) associated with bleeding related to the investigational device and/or radiofrequency ablation (RFA) procedure.
Measured: From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Severity of Bleeding-Related Adverse Events as Assessed by the Nashville Bleeding Scale
Safety assessments for bleeding Adverse Events (AEs) related to the investigational device and/or radiofrequency ablation (RFA) procedure, graded using the Nashville bleeding scale.
Measured: From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Secondary outcomes (6)
Total Number of Serious Adverse Events Related to the Investigational Device and/or RFA Procedure
Total number of Serious Adverse Events (SAEs) related to the investigational device and/or radiofrequency ablation (RFA) procedure.
Measured: From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Total Number of Adverse Events Related to the Investigational Device and/or RFA Procedure
Total number of Adverse Events (AEs) related to the investigational device and/or radiofrequency ablation (RFA) procedure.
Measured: From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Macroscopic and Microscopic Evidence of Ablation in the Resected Specimen
Macroscopic and microscopic evidence of ablation in the resected specimen, assessed using standard histopathological methods (hematoxylin and eosin staining).
Measured: At Surgical Resection (7-14 Days Post-Procedure)
Percentage of Tumor Necrosis Within the Ablation Zone
Visual estimation of histopathologic ablation completeness, defined as the percentage of tumor necrosis within the ablation zone, as determined by routine pathology reporting.
Measured: At Surgical Resection (7-14 Days Post-Procedure)
Histopathologic Complete Response (Absence of Viable Tumor Cells) Within the Ablation Zone
Evaluation of macroscopic and microscopic necrosis within the ablation zone, defined as the absence of viable tumor cells within the ablated area (histopathologic complete response, hpCR), if reported as part of routine histological assessment. If applicable, the extent of necrosis into surrounding parenchyma or margin tissue will be noted.
Measured: At Surgical Resection (7-14 Days Post-Procedure)
Composite Descriptive Intra-Procedural Metrics During Bronchoscopic Cryo-assisted RFA
Descriptive intra-procedural metrics collected during the bronchoscopic cryo-assisted radiofrequency ablation (RFA) procedure, including total ablation time (minutes), number of cryoRFA activations (energy applications), electrical parameters of energy delivered (if available), number of probe repositionings within the lesion, and estimated ablation zone size (millimeters) derived from intraoperative imaging when obtained as part of routine clinical practice. These measures are collected for descriptive characterization of procedural performance and are not intended for separate outcome analysis.
Measured: Day 0 (Diagnostic Bronchoscopy and RFA Procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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
- Model description
- Prospective, single-arm clinical investigation conducted at a single site.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carolin Steinack
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe Elektromedizin GmbH
- Responsible party
- Sponsor-investigator, Carolin Steinack, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398027
- Sponsor's protocol ID
- 639001022
- Acronym
- CRONOS-CH
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to local data protection requirements.
Publications
Signoretti M, Valente R, Repici A, Delle Fave G, Capurso G, Carrara S. Endoscopy-guided ablation of pancreatic lesions: Technical possibilities and clinical outlook. World J Gastrointest Endosc. 2017 Feb 16;9(2):41-54. doi: 10.4253/wjge.v9.i2.41.
PubMed 28250896Dabizzi E, Testoni SG, Barbera M et al. 484 EUS-GUIDED CRYOTHERM ABLATION OF STAGE III PANCREATIC ADENOCARCINOMA: A PRELIMINARY RADIOLOGICAL PERSPECTIVE. Gastrointest Endosc 2018; 87: AB84
Testoni SGG, Petrone MC, Reni M, Di Serio C, Rancoita PM, Rossi G, Balzano G, Linzenbold W, Enderle M, Della-Torre E, De Cobelli F, Falconi M, Capurso G, Arcidiacono PG. EUS-guided ablation with the HybridTherm Probe as second-line treatment in patients with locally advanced pancreatic ductal adenocarcinoma: A case-control study. Endosc Ultrasound. 2022 Sep-Oct;11(5):383-392. doi: 10.4103/EUS-D-21-00200.
PubMed 36255026Testoni SGG, Petrone MC, Reni M, Rossi G, Barbera M, Nicoletti V, Gusmini S, Balzano G, Linzenbold W, Enderle M, Della-Torre E, De Cobelli F, Doglioni C, Falconi M, Capurso G, Arcidiacono PG. Efficacy of Endoscopic Ultrasound-Guided Ablation with the HybridTherm Probe in Locally Advanced or Borderline Resectable Pancreatic Cancer: A Phase II Randomized Controlled Trial. Cancers (Basel). 2021 Sep 8;13(18):4512. doi: 10.3390/cancers13184512.
PubMed 34572743Arcidiacono PG, Carrara S, Reni M, Petrone MC, Cappio S, Balzano G, Boemo C, Cereda S, Nicoletti R, Enderle MD, Neugebauer A, von Renteln D, Eickhoff A, Testoni PA. Feasibility and safety of EUS-guided cryothermal ablation in patients with locally advanced pancreatic cancer. Gastrointest Endosc. 2012 Dec;76(6):1142-51. doi: 10.1016/j.gie.2012.08.006. Epub 2012 Sep 26.
PubMed 23021160Ahmed M, Liu Z, Afzal KS, Weeks D, Lobo SM, Kruskal JB, Lenkinski RE, Goldberg SN. Radiofrequency ablation: effect of surrounding tissue composition on coagulation necrosis in a canine tumor model. Radiology. 2004 Mar;230(3):761-7. doi: 10.1148/radiol.2303021801.
PubMed 14990840International Conference on Harmonization (ICH) Guideline for Good Clinical Practice E6(R2), (www.ich.org).
Strahlenschutzverordnung (StSV) vom 26. April 2017 / Ordonnance sur la radioprotection (ORaP) du 26 avril 2017 / Ordinanza sulla radioprotezione (ORaP) del 26 aprile 2017
WHO, International Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/en/)
EN ISO 14971: Application of risk management to medical devices (www.iso.org)
EN ISO 10993: Biological evaluation of medical devices (www.iso.org)
EN ISO 14155: Clinical investigation of medical devices for human subjects - Good clinical practice (www.iso.org)
MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 (https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020-10-1_guidance_safety_reporting_en.pdf)
MDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices
Medical Device Regulation (EU) 2017/745 of 5 April 2017 (MDR)
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study of Transbronchial Cryo-assisted RFA During Robotic Assisted Bronchoscopy With Subsequent Surgical Resection (CRONOS-CH)
- ClinicalTrials.gov ID
- NCT07398027
- Acronym / sponsor ID
- CRONOS-CH / 639001022
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Carolin SteinackUniversity, hospital or other
- Collaborators
- Erbe Elektromedizin GmbH
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Feb 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.
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.
Detailed description
This is a prospective, single-arm, post-market clinical investigation conducted in Switzerland to collect clinical data on the use, safety, and performance of the CE-marked HybridTherm® system during routine bronchoscopic tumor management procedures. The investigation is classified as a ClinO-MD Category A1 medical device study, as the HybridTherm® system is CE-marked and used strictly within its intended purpose under normal conditions of clinical use.
The investigation is investigator-initiated and single-center, conducted at the University Hospital Zurich. The Sponsor-Investigator is responsible for the initiation, conduct, management, safety oversight, and data handling of the study in accordance with the Swiss Human Research Act (HRA), the Ordinance on Clinical Trials with Medical Devices (ClinO-MD), ISO 14155, and applicable ethical requirements. Ethics Committee approval is required prior to study initiation, and the investigation will begin only after a positive written decision from the competent cantonal ethics committee has been obtained.
The HybridTherm® system is a bipolar cryo-cooled radiofrequency ablation device intended for incision, coagulation, and ablation of tissue during flexible endoscopic procedures in the tracheobronchial system. The system provides internally cooled radiofrequency energy to delay tissue desiccation and impedance rise, thereby enabling controlled energy delivery during ablation. In this investigation, the device is used during clinically indicated bronchoscopic procedures without deviation from its approved indication or standard clinical workflow.
All enrolled participants undergo diagnostic bronchoscopy as part of routine clinical care, including mediastinal lymph node staging when clinically indicated. Transbronchial cryo-assisted radiofrequency ablation is performed during the same bronchoscopy session under general anesthesia. Surgical resection of the targeted lung lesion follows according to the established oncologic treatment plan and is not altered by study participation. No randomization, blinding, or comparator intervention is included.
Data collected in this investigation are derived exclusively from standard-of-care procedures, routine imaging, device readouts, and histopathological assessment of resected specimens. No additional diagnostic tests, therapeutic interventions, or protocol-mandated procedures beyond routine clinical practice are introduced. All analyses are descriptive in nature and are intended to support post-market evaluation of procedural feasibility, safety, and device usability.
The investigation is designed to generate clinical experience and safety data that may inform future clinical research and support the continued evaluation of bronchoscopic cryo-assisted radiofrequency ablation using the HybridTherm® system within standard treatment pathways.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm clinical investigation conducted at a single site.
| Arm | Type | Receives |
|---|---|---|
| HybridTherm Cryo-Assisted RFA & surgical resection | Experimental | Device: HybridTherm® SystemParticipants undergo transbronchial cryo-assisted radiofrequency ablation (RFA) using the CE-marked HybridTherm® system during routine diagnostic bronchoscopy. When clinically indicated, mediastinal lymph node staging by performed. Surgical resection of the treated lung lesion follows according to the standard clinical treatment plan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| HybridTherm® SystemTransbronchial cryo-assisted radiofrequency ablation (RFA) performed using the CE-marked HybridTherm® system during routine diagnostic bronchoscopy, within the intended use of the device. | Device | HybridTherm Cryo-Assisted RFA & surgical resection |
Primary outcome
Number of Participants with Successful Completion of Bronchoscopic Cryo-assisted RFA Using the HybridTherm® System
Time frame: Day 0 (Diagnostic Bronchoscopy and RFA Procedure)
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
Number of Participants with Bleeding-Related Serious Adverse Events Associated with the Investigational Device and/or RFA Procedure
Time frame: From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Number of Serious Adverse Events (SAEs) associated with bleeding related to the investigational device and/or radiofrequency ablation (RFA) procedure.
Severity of Bleeding-Related Adverse Events as Assessed by the Nashville Bleeding Scale
Time frame: From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Safety assessments for bleeding Adverse Events (AEs) related to the investigational device and/or radiofrequency ablation (RFA) procedure, graded using the Nashville bleeding scale.
6 secondary outcomes
Total Number of Serious Adverse Events Related to the Investigational Device and/or RFA Procedure
Time frame: From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Total Number of Adverse Events Related to the Investigational Device and/or RFA Procedure
Time frame: From Day 0 (Diagnostic Bronchoscopy and RFA Procedure) through End of Study (6-7 weeks post-procedure)
Macroscopic and Microscopic Evidence of Ablation in the Resected Specimen
Time frame: At Surgical Resection (7-14 Days Post-Procedure)
Percentage of Tumor Necrosis Within the Ablation Zone
Time frame: At Surgical Resection (7-14 Days Post-Procedure)
Histopathologic Complete Response (Absence of Viable Tumor Cells) Within the Ablation Zone
Time frame: At Surgical Resection (7-14 Days Post-Procedure)
Composite Descriptive Intra-Procedural Metrics During Bronchoscopic Cryo-assisted RFA
Time frame: Day 0 (Diagnostic Bronchoscopy and RFA Procedure)
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 9 Feb 2026.
- Background: PubMed 28250896Signoretti M, Valente R, Repici A, Delle Fave G, Capurso G, Carrara S. Endoscopy-guided ablation of pancreatic lesions: Technical possibilities and clinical outlook. World J Gastrointest Endosc. 2017 Feb 16;9(2):41-54. doi: 10.4253/wjge.v9.i2.41.
- BackgroundDabizzi E, Testoni SG, Barbera M et al. 484 EUS-GUIDED CRYOTHERM ABLATION OF STAGE III PANCREATIC ADENOCARCINOMA: A PRELIMINARY RADIOLOGICAL PERSPECTIVE. Gastrointest Endosc 2018; 87: AB84
- Background: PubMed 36255026Testoni SGG, Petrone MC, Reni M, Di Serio C, Rancoita PM, Rossi G, Balzano G, Linzenbold W, Enderle M, Della-Torre E, De Cobelli F, Falconi M, Capurso G, Arcidiacono PG. EUS-guided ablation with the HybridTherm Probe as second-line treatment in patients with locally advanced pancreatic ductal adenocarcinoma: A case-control study. Endosc Ultrasound. 2022 Sep-Oct;11(5):383-392. doi: 10.4103/EUS-D-21-00200.
- Background: PubMed 34572743Testoni SGG, Petrone MC, Reni M, Rossi G, Barbera M, Nicoletti V, Gusmini S, Balzano G, Linzenbold W, Enderle M, Della-Torre E, De Cobelli F, Doglioni C, Falconi M, Capurso G, Arcidiacono PG. Efficacy of Endoscopic Ultrasound-Guided Ablation with the HybridTherm Probe in Locally Advanced or Borderline Resectable Pancreatic Cancer: A Phase II Randomized Controlled Trial. Cancers (Basel). 2021 Sep 8;13(18):4512. doi: 10.3390/cancers13184512.
- Background: PubMed 23021160Arcidiacono PG, Carrara S, Reni M, Petrone MC, Cappio S, Balzano G, Boemo C, Cereda S, Nicoletti R, Enderle MD, Neugebauer A, von Renteln D, Eickhoff A, Testoni PA. Feasibility and safety of EUS-guided cryothermal ablation in patients with locally advanced pancreatic cancer. Gastrointest Endosc. 2012 Dec;76(6):1142-51. doi: 10.1016/j.gie.2012.08.006. Epub 2012 Sep 26.
- Background: PubMed 14990840Ahmed M, Liu Z, Afzal KS, Weeks D, Lobo SM, Kruskal JB, Lenkinski RE, Goldberg SN. Radiofrequency ablation: effect of surrounding tissue composition on coagulation necrosis in a canine tumor model. Radiology. 2004 Mar;230(3):761-7. doi: 10.1148/radiol.2303021801.
- BackgroundInternational Conference on Harmonization (ICH) Guideline for Good Clinical Practice E6(R2), (www.ich.org).
- BackgroundStrahlenschutzverordnung (StSV) vom 26. April 2017 / Ordonnance sur la radioprotection (ORaP) du 26 avril 2017 / Ordinanza sulla radioprotezione (ORaP) del 26 aprile 2017
- BackgroundWHO, International Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/en/)
- BackgroundEN ISO 14971: Application of risk management to medical devices (www.iso.org)
- BackgroundEN ISO 10993: Biological evaluation of medical devices (www.iso.org)
- BackgroundEN ISO 14155: Clinical investigation of medical devices for human subjects - Good clinical practice (www.iso.org)
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to local data protection requirements.
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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.
Dr. Carolin Steinack, Head of Interventional Pulmonology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HybridTherm® System in people with Lung Cancer, run by Carolin Steinack at 1 site in Switzerland.
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 7 inclusion and 13 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 9 Feb 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 Switzerland. 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 Dr. Carolin Steinack, Head of Interventional Pulmonology (+41 76 771 37 79, carolin.steinack@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Successful Completion of Bronchoscopic Cryo-assisted RFA Using the HybridTherm® System (time frame: Day 0 (Diagnostic Bronchoscopy and RFA Procedure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07398027, which also lists 54 linked publications.
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 9 Feb 2026.