Lung CancerAB1MALTISC-UKNCT06869122
Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK
An observational study of Lung Cancer, run by Creo Medical Limited at 2 sites in 2 countries.
Trial summary
This study involves the use of a medical device, the Creo Medical MicroBlate Flex instrument, to heat and destroy lung tumour cells using microwave energy (this is also called ablation). 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?
- Ablation
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Jul 2025to Dec 2026
- Phase
- Observational
- 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
Study population: General population going through lung cancer screening at investigative site.
Who may be able to join
- Patients who:
- Have signed informed consent.
- Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
- Are ≥ 18 years old.
- Have lung lesion(s)/nodule(s) which are histopathological confirmed as cancer.
- Have soft tissue lung lesion(s):
Show all 11Show fewer
- ≤ 20 mm in the largest dimension of the pulmonary window
- Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
- > 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure.
- Subject is willing and able to comply with the study protocol requirements.
- Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.
Who cannot join
- Patients who:
- 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).
- Are pregnant or breast feeding, as determined by standard site practices.
- Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
- Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
- Have an expected survival less than 12 months.
Show all 12Show fewer
- Have an implantable device, including pacemakers or other electronic implants.
- Have known pulmonary hypertension (PASP [pulmonary artery systolic pressure] >50mmHg).
- Subject had a prior pneumonectomy.
- Diagnosis of Small Cell Lung Cancer.
- Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion.
- Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Not yet recruiting
Istituto Europeo di Oncologia (IEO), Via Ripamonti 435
Milan, 20141
Juliana Guarize, +39 0257489665, juliana.guarize@ieo.it
Giulia Sedda, +39 0294372178, giulia.sedda@ieo.it
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton and Harefield NHS Foundation Trust, Royal Brompton Hospital, Sydney Street
London, UK, SW3 6NP
Elif Agaoglu, +44 207 351 8029, E.Agaoglu@rbht.nhs.uk
Harris Trainer, harris.trainer@nhs.net
About this study
Official title: Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK
This study involves the use of a medical device, the Creo Medical MicroBlate Flex instrument, to heat and destroy lung tumour cells using microwave energy (this is also called ablation). In this study, the investigators are investigating whether the ablation instrument can be used effectively to treat lung tumours or tumours that have spread to the lungs. If successful, using this technology may mean future patients may not need to undergo surgical removal of these types of lung tumours.
The aim of this study is to evaluate the safety and performance of the MicroBlate Flex instrument in treating individuals with cancerous lung tumours that are due to be removed by surgery. All participants in the study will undergo the microwave ablation procedure, which is a separate and additional procedure to their surgical procedure.
The study, funded by Creo Medical, will be conducted at sites in the UK and Italy, and will involve up to 18 participants.
Read the detailed description
Participation (approximately 2 months) in this study, will include a screening visit, a bronchoscopy procedure that includes the microwave ablation treatment, and the planned surgical removal of the lung tumour 7 to 21 days after the ablation.
There are 2 follow-up visits, one at 7 days after the ablation treatment, the second just before the planned surgical procedure. After surgery, patients will be monitored according to the hospital's routine clinical practice. Participation in the research study ends once the patient is discharged from hospital.
Participation in this study has the potential to provide the following benefits for other people who have the same medical condition:
- The option of choosing microwave ablation as an alternative treatment for lung tumours and avoiding a major surgical procedure.
- Shorter patient recovery times.
- Reduced incidence of complications.
- Conditions
- Lung Cancer
- Being tested
- Ablation
- Keywords
- Bronchoscopy, Ablation, Microwave, Lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationDevice
Bronchoscopy and microwave ablation of the lung tumour prior to surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation | Patients with a malignant lung nodule who are candidates for surgical resection. Receives: Device: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the MicroBlate Flex AB1 system in lung tumour ablation
Identification of serious device-related adverse events associated with the delivery of microwave energy by the AB1 system from ablation (Day 0) up to the first surgical incision for the resection (Day 7-21)
Measured: Up to 21 days after the ablation procedure
Technical Success and Performance of the AB1 instrument
Initial technical success, defined as successful bronchoscopic access by the AB1 instrument of the target tissue, delivery of the scheduled microwave energy to the target tissue (per pre-specified target) and confirmed ablation as evidenced by macroscopic assessment post-surgical resection of the ablated lesion
Measured: Up to 28 days post ablation procedure
Secondary outcomes (4)
Assessment/visualization/quantification of the dimensions of the ablated tissue including assessment of margin relative to lesion
Dimensions of the ablated tissue to confirm, correct or add to the IFU-reported relationship between AB1 ablation time and dimensions and volume of the ablated tissue, per pre-specified target
Measured: Up to 1 week post surgical resection procedure
Assessment/visualization/quantification of the dimensions of the ablation observed within the post-ablation CT
Dimensions of the ablated tissue as evidenced on the post-ablation CT
Measured: Up to 1 week post ablation procedure
Procedural Time
Procedural time to be captured in the electronic case report form
Measured: Up to 1 week post ablation procedure
Assessment of ease of system use (Clinician Questionnaires)
Questionnaires to be completed by clinicians following each procedure, rating their responses on a Likert scale of 1 to 7, with 1 being "extremely clear/easy" and 7 being "extremely difficult"
Measured: Up to 1 week post ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start14 Jul 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creo Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869122
- Sponsor's protocol ID
- PD-GTD-AB1UK-003
- Acronym
- AB1MALTISC-UK
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summary aggregate information will be published in a PRJA at the conclusion of the study.
Publications
Chang et al The Lancet Oncology 2015 Vol 16, Issue 6, 630 - 637
SABR UK Consortium. "Stereotactic Ablative Body Radiation Therapy (SABR): A Resource." Version 6.1. January 2019.
Chen 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.
PubMed 28581404Boffa 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.
PubMed 18242243Licker 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.
PubMed 16631680Covey 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.
PubMed 15126658
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK
- ClinicalTrials.gov ID
- NCT06869122
- Acronym / sponsor ID
- AB1MALTISC-UK / PD-GTD-AB1UK-003
- Conditions
- Lung Cancer
- Keywords
- Bronchoscopy, Ablation, Microwave, Lung cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Creo Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Mar 2025 (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.
This study involves the use of a medical device, the Creo Medical MicroBlate Flex instrument, to heat and destroy lung tumour cells using microwave energy (this is also called ablation). In this study, the investigators are investigating whether the ablation instrument can be used effectively to treat lung tumours or tumours that have spread to the lungs. If successful, using this technology may mean future patients may not need to undergo surgical removal of these types of lung tumours.
The aim of this study is to evaluate the safety and performance of the MicroBlate Flex instrument in treating individuals with cancerous lung tumours that are due to be removed by surgery. All participants in the study will undergo the microwave ablation procedure, which is a separate and additional procedure to their surgical procedure.
The study, funded by Creo Medical, will be conducted at sites in the UK and Italy, and will involve up to 18 participants.
Detailed description
Participation (approximately 2 months) in this study, will include a screening visit, a bronchoscopy procedure that includes the microwave ablation treatment, and the planned surgical removal of the lung tumour 7 to 21 days after the ablation.
There are 2 follow-up visits, one at 7 days after the ablation treatment, the second just before the planned surgical procedure. After surgery, patients will be monitored according to the hospital's routine clinical practice. Participation in the research study ends once the patient is discharged from hospital.
Participation in this study has the potential to provide the following benefits for other people who have the same medical condition:
- The option of choosing microwave ablation as an alternative treatment for lung tumours and avoiding a major surgical procedure.
- Shorter patient recovery times.
- Reduced incidence of complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave ablation | – | Device: AblationPatients with a malignant lung nodule who are candidates for surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population going through lung cancer screening at investigative site.
Key inclusion criteria (11 listed)
- Have signed informed consent.
- Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
- Are ≥ 18 years old.
- Have lung lesion(s)/nodule(s) which are histopathological confirmed as cancer.
- Have soft tissue lung lesion(s):
Key exclusion criteria (12 listed)
- 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).
- Are pregnant or breast feeding, as determined by standard site practices.
- Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
- Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
- Have an expected survival less than 12 months.
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 |
|---|---|---|
| AblationBronchoscopy and microwave ablation of the lung tumour prior to surgical resection. | Device | Microwave ablation |
Primary outcome
Safety of the MicroBlate Flex AB1 system in lung tumour ablation
Time frame: Up to 21 days after the ablation procedure
Identification of serious device-related adverse events associated with the delivery of microwave energy by the AB1 system from ablation (Day 0) up to the first surgical incision for the resection (Day 7-21)
Technical Success and Performance of the AB1 instrument
Time frame: Up to 28 days post ablation procedure
Initial technical success, defined as successful bronchoscopic access by the AB1 instrument of the target tissue, delivery of the scheduled microwave energy to the target tissue (per pre-specified target) and confirmed ablation as evidenced by macroscopic assessment post-surgical resection of the ablated lesion
4 secondary outcomes
Assessment/visualization/quantification of the dimensions of the ablated tissue including assessment of margin relative to lesion
Time frame: Up to 1 week post surgical resection procedure
Assessment/visualization/quantification of the dimensions of the ablation observed within the post-ablation CT
Time frame: Up to 1 week post ablation procedure
Procedural Time
Time frame: Up to 1 week post ablation procedure
Assessment of ease of system use (Clinician Questionnaires)
Time frame: Up to 1 week post ablation 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 21 Apr 2026.
- BackgroundChang et al The Lancet Oncology 2015 Vol 16, Issue 6, 630 - 637
- BackgroundSABR UK Consortium. "Stereotactic Ablative Body Radiation Therapy (SABR): A Resource." Version 6.1. January 2019.
- Background: PubMed 28581404Chen 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.
- Background: PubMed 18242243Boffa 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.
- Background: PubMed 16631680Licker 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.
- Background: PubMed 15126658Covey 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.
- Individual participant dataSharing planned: Yes. Summary aggregate information will be published in a PRJA at the conclusion of the study.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Creo Medical Limited at 2 sites in 2 countries.
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 11 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 21 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 2 sites in Italy, United Kingdom. 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 Charlie Campion (+44 7939 600137, Charlie.Campion@creomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the MicroBlate Flex AB1 system in lung tumour ablation (time frame: Up to 21 days after the ablation procedure). The study lists 2 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 NCT06869122, which also lists 6 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 21 Apr 2026.