Clinical trial · Observational
Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates
Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates
NCT06689488CI-TRIAL-00115993AB1MALTISCrecruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
The overall purpose of this study is to characterise the clinical safety and performance of the Creo Medical MicroBlate™ Flex AB1 instrument in patients with pathologically confirmed malignancy eligible for surgical resection of their nodule, receiving bronchoscopic ablation prior to surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Microwave ablation
- description
- Patients with a malignant lung nodule who are candidates for surgical resection.
- interventionNames
- Device: Ablation
Primary outcomes (3)
- measure
- Primary Safety Endpoint
- timeFrame
- Day 0, day of ablation procedure up to initiation of surgical resection procedure.
- description
- Stage A - Ablate (Day 0) \& Resect (Day 0) Identification of serious device-related intra-procedural adverse events related to the use of the AB1 system on Day 0 prior to surgical resection defined by the initial skin incision (number and nature of serious adverse events, both device and procedure related, will be identified).
- measure
- Primary Safety Endpoint
- timeFrame
- Day 7-21, post ablation procedure up to initiation of surgical resection procedure.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients who: 1. Have signed informed consent. 2. Subject is willing and able to comply with all aspects of the treatment and evaluation schedule. 3. Are ≥ 18 years old. 4. Have lung lesion(s)/nodule(s) which are histopathological-confirmed as cancer. 5. Have soft tissue lung lesion(s): * ≤ 30 mm in the largest dimension of the pulmonary window for Stage A. * ≤ 20 mm in the largest dimension of the pulmonary window for Stage B. 6. Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board. 7. Greater than 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure. 8. Subject is willing and able to comply with the study protocol requirements. 9. Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia. Exclusion Criteria: Patients who: 1. Have target nodule(s) within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord, and phrenic \& laryngeal nerves). 2. Are pregnant or breast feeding, as determined by standard site practices. 3. Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study. 4. Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject. 5. Have an expected survival less than 12 months. 6. Have bleeding diathesis, uncorrectable coagulopathy, or platelet count ≤ 100 x 10\^9/L. 7. Have an implantable device, including pacemakers or other electronic implants. 8. Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \>50mmHg). 9. Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which can´t be stopped or temporarily withheld. 10. Subject had a prior pneumonectomy. 11. Diagnosis of Small Cell Lung Cancer. 12. Any patient with clinically significant interstitial lung disease in the zone of planned ablation. 13. Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion. 14. Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.
References
Publications (6)
- BACKGROUNDCovey AM, Gandhi R, Brody LA, Getrajdman G, Thaler HT, Brown KT. Factors associated with pneumothorax and pneumothorax requiring treatment after percutaneous lung biopsy in 443 consecutive patients. J Vasc Interv Radiol. 2004 May;15(5):479-83. doi: 10.1097/01.rvi.0000124951.24134.50. PMID 15126658
- BACKGROUNDLicker MJ, Widikker I, Robert J, Frey JG, Spiliopoulos A, Ellenberger C, Schweizer A, Tschopp JM. Operative mortality and respiratory complications after lung resection for cancer: impact of chronic obstructive pulmonary disease and time trends. Ann Thorac Surg. 2006 May;81(5):1830-7. doi: 10.1016/j.athoracsur.2005.11.048. PMID 16631680
- BACKGROUNDBoffa DJ, Allen MS, Grab JD, Gaissert HA, Harpole DH, Wright CD. Data from The Society of Thoracic Surgeons General Thoracic Surgery database: the surgical management of primary lung tumors. J Thorac Cardiovasc Surg. 2008 Feb;135(2):247-54. doi: 10.1016/j.jtcvs.2007.07.060. Epub 2007 Dec 21. PMID 18242243
- BACKGROUNDChen H, Senan S, Nossent EJ, Boldt RG, Warner A, Palma DA, Louie AV. Treatment-Related Toxicity in Patients With Early-Stage Non-Small Cell Lung Cancer and Coexisting Interstitial Lung Disease: A Systematic Review. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):622-631. doi: 10.1016/j.ijrobp.2017.03.010. Epub 2017 Mar 15. PMID 28581404
- BACKGROUNDSABR UK Consortium. "Stereotactic Ablative Body Radiation Therapy (SABR): A Resource." Version 6.1. January 2019
- BACKGROUNDChang et al The Lancet Oncology 2015 Vol 16, Issue 6, 630 - 637