Lung CancerAB1MALTNCT05786625
Bronchoscopic Microwave Ablation of Lung Tissue
An observational study of Lung Cancer, run by Creo Medical Limited at 2 sites in 2 countries.
Trial summary
The primary purpose of this study is to evaluate the safety and feasibility of the Creo Medical MicroBlate™ Flex AB1 instrument used with the AB1 electrosurgical system in patients undergoing bronchoscopic microwave ablation of peripheral lung nodules. 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
- 35 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 May 2023to 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: Subjects enrolled in the proposed study must have a suitable soft tissue lung lesion and be candidates for an elective endobronchial navigation and microwave ablation procedure performed bronchoscopically. Patients without a histologically confirmed diagnosis of cancer may be enrolled if a multi-disciplinary board deems that it is highly likely that their lung lesion is a malignancy.
Who may be able to join
- The participant may enter the study if ALL of the following apply:
- The patient:
- Has signed the informed consent form
- Are ≥ 18 years old
- Has lung lesion(s)/nodule(s) which are histologically confirmed or highly suspicious for cancer and is a candidate for bronchoscopic microwave ablation (as determined by a multi-disciplinary team (MDT) or tumour board).
- Has a medically inoperable soft tissue lung lesion(s) ≤ 20 mm (suspected or confirmed malignancy), or patient has elected not to have surgery / alternative therapy.
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- Patient is a candidate for bronchoscopy under general anaesthesia.
- 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
- The participant may not be enrolled in the study if ANY of the following apply:
- For patients undergoing procedures employing robotic-assisted bronchoscopy:
- 1. a. Target nodule(s) are within 10mm of the trachea, right and left main bronchus, aorta, central pulmonary arteries, heart, oesophagus, spinal cord, phrenic \& laryngeal nerves.
- Note: Exclusion Criteria 1a is UK-specific.
- For patients undergoing procedures without the use of robotic-assisted bronchoscopy (manual procedures):
- b. Target nodule(s) are within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord and phrenic and laryngeal nerves), or are <10 mm from the pleura.
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- Are assigned status 4 via ECOG (Eastern Cooperative Oncology Group) classification.
- 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.
- Are scheduled for concurrent interventional procedure for the target soft tissue lesion.
- Have a physical or psychological condition or other factor(s) that would impair study participation, or jeopardise the safety or welfare of the subject.
- Have an expected survival less than 6 months.
- Have patients with bleeding diathesis, uncorrectable coagulopathy or platelet count ≤ 100 x 10⁹ /L.
- Have an implantable devices, including pacemakers or other electronic implants.
- Have known pulmonary hypertension (PASP [pulmonary artery systolic pressure] > 50mmHg).
- Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which cannot be stopped or temporarily withheld.
- Any patient with clinically significant interstitial lung disease in the zone of planned ablation.
- Note: Exclusion Criteria 12 is NL-specific.
- Patient has nodal disease confirmed through invasive or image-based staging. Note: if nodal disease is suspected or detected during the staging procedure conducted prior to use of the investigational device during the study procedure, the subject will be excluded.
- Subject had a prior pneumonectomy.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Amsterdam University Medical Centres, Location AMC, Meibergdreef 9
Amsterdam, 1105 AZ
United Kingdom1 site
Royal Brompton and Harefield NHS Foundation Trust
London, SW3 6NP
About this study
Official title: Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue
The primary purpose of this study is to evaluate the safety and feasibility of the Creo Medical MicroBlate™ Flex AB1 instrument used with the AB1 electrosurgical system in patients undergoing bronchoscopic microwave ablation of peripheral lung nodules.
Read the detailed description
This is a post-market, prospective, single-arm, multicentre, non-randomized, observational study which will enrol up to 35 subjects in total (plus replacements) at up to 6 clinical investigation sites in Europe and potentially 1 site in the US.
Prospective patients must have a suitable soft tissue lung lesion and be candidates for an elective endobronchial navigation and microwave ablation procedure performed bronchoscopically. After being informed about the study and potential risks, all patients giving their written informed consent will undergo a screening visit to determine eligibility for study entry. Patients who meet the eligibility requirements will undergo a pre-procedural assessment, a bronchoscopy procedure that includes ablation treatment with MicroBlate™ Flex AB1, a post-procedural assessment and 6 follow-up visits at, 7 days (by phone call or in person), 31-45 days, 3 months, 6 months, 9 months and 12 months.
- Conditions
- Lung Cancer
- Being tested
- Ablation
- Keywords
- Neoplasms, Bronchoscopy, Ablation, Microwave
- Medical subject headings
- Lung Neoplasms, 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 lung nodule
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation | Patients with a single or multiple soft tissue lung lesions that is medically inoperable or for which the patient has declined surgical resection. Receives: Device: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Performance (Efficacy) Endpoint
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 and confirmed ablation as evidenced by assessment of CT.
The criterion for meeting the Performance (efficacy) endpoint excludes study system malfunctions.
Measured: Up to day 30 patient visit.
Primary Safety Endpoint
Identification of serious device-related adverse events related to the use of the AB1 system up to 30 days after the ablation procedure (number and nature of serious adverse events, both device- and procedure- related, will be identified) including, but not limited to:
- Moderate bleeding (intervention required such as use of balloon tamponade or Surgicel) or severe bleeding (prolonged monitoring necessary or fatal bleeding)
- Pneumothorax
- Failure of extubation
- ICU admission for respiratory failure within 30 days
- Death within 30 days.
Measured: Up to 30 days after the ablation procedure.
Secondary outcomes (8)
Secondary Safety Endpoint
Identification of all device-related, procedure related and other adverse events related to bronchoscopic microwave ablation interventions using the AB1 system.
Measured: Up to 12 months post ablation.
Secondary Effectiveness Outcomes - Rate of tumor recurrence
Rate of recurrence at all time points as determined by the multidisciplinary team (MDT) or tumour board.
Measured: Up to 12 months
Secondary Effectiveness Outcomes - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C)
Patients will rate their responses from 1 to 4 on a Likert Scale (1 being "not at all" and 4 being "very much").
Measured: Up to 12 months
Secondary Effectiveness Outcomes - EQ-5D-5L health-related quality of life questionnaire
Patients complete the 5 level descriptive system relating to 5 dimensions of health and the EQ visual analogue scale from 0 to 100 (where 0 means the worst health you can imagine and 100 means the best health you can imagine).
Measured: Up to 12 months
Secondary Effectiveness Outcomes - Patient-reported pain rating on a visual analogue scale
Patients will rate their pain on a visual analogue scale from 0 to 10 (where 0 is no pain and 10 is the most severe pain).
Measured: Up to 45 days post-ablation
Secondary Effectiveness Outcomes - Assessment/visualization/quantification of the dimensions of the ablated tissue
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 12 months
Secondary Effectiveness Outcomes - Procedural Time
Procedural time to be captured in the electronic case report form (eCRF).
Measured: Up to 1 day post ablation procedure.
Secondary Effectiveness Outcomes - Assessment of ease of system use (clinician questionnaires)
Questionnaires to be completed by clinicians, rating their responses on a Likert scale of 1 to 7, with 1 being "extremely easy" and 7 being "extremely difficult".
Measured: Up to 1 day 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 posted27 Mar 2023
- Study start4 May 2023
- Primary completion26 Nov 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creo Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pallav L Shah, MD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786625
- Sponsor's protocol ID
- 8-AB1-950
- Acronym
- AB1MALT
- Status last verified
- Jan 2026
- First submitted
- 27 Feb 2023
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Single site
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 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
- ClinicalTrials.gov ID
- NCT05786625
- Acronym / sponsor ID
- AB1MALT / 8-AB1-950
- Conditions
- Lung Cancer
- Keywords
- Neoplasms, Bronchoscopy, Ablation, Microwave
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Creo Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 May 2023 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Mar 2023 (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 primary purpose of this study is to evaluate the safety and feasibility of the Creo Medical MicroBlate™ Flex AB1 instrument used with the AB1 electrosurgical system in patients undergoing bronchoscopic microwave ablation of peripheral lung nodules.
Detailed description
This is a post-market, prospective, single-arm, multicentre, non-randomized, observational study which will enrol up to 35 subjects in total (plus replacements) at up to 6 clinical investigation sites in Europe and potentially 1 site in the US.
Prospective patients must have a suitable soft tissue lung lesion and be candidates for an elective endobronchial navigation and microwave ablation procedure performed bronchoscopically. After being informed about the study and potential risks, all patients giving their written informed consent will undergo a screening visit to determine eligibility for study entry. Patients who meet the eligibility requirements will undergo a pre-procedural assessment, a bronchoscopy procedure that includes ablation treatment with MicroBlate™ Flex AB1, a post-procedural assessment and 6 follow-up visits at, 7 days (by phone call or in person), 31-45 days, 3 months, 6 months, 9 months and 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave ablation | – | Device: AblationPatients with a single or multiple soft tissue lung lesions that is medically inoperable or for which the patient has declined surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects enrolled in the proposed study must have a suitable soft tissue lung lesion and be candidates for an elective endobronchial navigation and microwave ablation procedure performed bronchoscopically. Patients without a histologically confirmed diagnosis of cancer may be enrolled if a multi-disciplinary board deems that it is highly likely that their lung lesion is a malignancy.
Key inclusion criteria (9 listed)
- Has signed the informed consent form
- Are ≥ 18 years old
- Has lung lesion(s)/nodule(s) which are histologically confirmed or highly suspicious for cancer and is a candidate for bronchoscopic microwave ablation (as determined by a multi-disciplinary team (MDT) or tumour board).
- Has a medically inoperable soft tissue lung lesion(s) ≤ 20 mm (suspected or confirmed malignancy), or patient has elected not to have surgery / alternative therapy.
- Patient is a candidate for bronchoscopy under general anaesthesia.
Key exclusion criteria (20 listed)
- 1. a. Target nodule(s) are within 10mm of the trachea, right and left main bronchus, aorta, central pulmonary arteries, heart, oesophagus, spinal cord, phrenic \& laryngeal nerves.
- Note: Exclusion Criteria 1a is UK-specific.
- For patients undergoing procedures without the use of robotic-assisted bronchoscopy (manual procedures):
- b. Target nodule(s) are within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord and phrenic and laryngeal nerves), or are <10 mm from the pleura.
- Are assigned status 4 via ECOG (Eastern Cooperative Oncology Group) classification.
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 lung nodule | Device | Microwave ablation |
Primary outcome
Primary Performance (Efficacy) Endpoint
Time frame: Up to day 30 patient visit.
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 and confirmed ablation as evidenced by assessment of CT. The criterion for meeting the Performance (efficacy) endpoint excludes study system malfunctions.
Primary Safety Endpoint
Time frame: Up to 30 days after the ablation procedure.
Identification of serious device-related adverse events related to the use of the AB1 system up to 30 days after the ablation procedure (number and nature of serious adverse events, both device- and procedure- related, will be identified) including, but not limited to: * Moderate bleeding (intervention required such as use of balloon tamponade or Surgicel) or severe bleeding (prolonged monitoring necessary or fatal bleeding) * Pneumothorax * Failure of extubation * ICU admission for respiratory failure within 30 days * Death within 30 days.
8 secondary outcomes
Secondary Safety Endpoint
Time frame: Up to 12 months post ablation.
Secondary Effectiveness Outcomes - Rate of tumor recurrence
Time frame: Up to 12 months
Secondary Effectiveness Outcomes - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C)
Time frame: Up to 12 months
Secondary Effectiveness Outcomes - EQ-5D-5L health-related quality of life questionnaire
Time frame: Up to 12 months
Secondary Effectiveness Outcomes - Patient-reported pain rating on a visual analogue scale
Time frame: Up to 45 days post-ablation
Secondary Effectiveness Outcomes - Assessment/visualization/quantification of the dimensions of the ablated tissue
Time frame: Up to 12 months
Secondary Effectiveness Outcomes - Procedural Time
Time frame: Up to 1 day post ablation procedure.
Secondary Effectiveness Outcomes - Assessment of ease of system use (clinician questionnaires)
Time frame: Up to 1 day 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 2 Feb 2026.
- Individual participant dataSharing planned: Undecided. Single site
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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. This study is not recruiting at the moment.
Pallav L Shah, MD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
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 9 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 2 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 2 sites in Netherlands, 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Performance (Efficacy) Endpoint (time frame: Up to day 30 patient visit.). 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?
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 2 Feb 2026.