New microwave tool targets lung tumors without surgery
NCT ID NCT05786625
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new device that uses microwave energy to destroy small lung tumors. The device is inserted through a bronchoscope, avoiding the need for open surgery. The trial will enroll 35 people with lung nodules that are cancerous or highly suspicious, and who cannot have surgery. Researchers will check if the device can safely reach and ablate the tumor, and monitor for side effects like bleeding or lung collapse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Microwave ablation device (MicroBlate™ Flex AB1)
- What this could lead to
- If successful, this could provide a new, less invasive treatment option for people with small lung tumors who cannot have surgery.
- What could go wrong
- This is an early feasibility study with only 35 participants. The device may cause serious side effects like bleeding or lung collapse, and it is not yet proven to control cancer long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
35 people
The number who actually took part.
- Started
-
May 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: The participant may enter the study if ALL of the following apply: The patient: 1. Has signed the informed consent form 2. Are ≥ 18 years old 3. 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). 4. 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. 5. Patient is a candidate for bronchoscopy under general anaesthesia. 6. Subject is willing and able to comply with the study protocol requirements. 7. Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia. Exclusion Criteria: 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): 1. 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. 2. Are assigned status 4 via ECOG (Eastern Cooperative Oncology Group) classification. 3. Are pregnant or breast feeding, as determined by standard site practices. 4. Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study. 5. Are scheduled for concurrent interventional procedure for the target soft tissue lesion. 6. Have a physical or psychological condition or other factor(s) that would impair study participation, or jeopardise the safety or welfare of the subject. 7. Have an expected survival less than 6 months. 8. Have patients with bleeding diathesis, uncorrectable coagulopathy or platelet count ≤ 100 x 10⁹ /L. 9. Have an implantable devices, including pacemakers or other electronic implants. 10. Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \> 50mmHg). 11. Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which cannot be stopped or temporarily withheld. 12. Any patient with clinically significant interstitial lung disease in the zone of planned ablation. Note: Exclusion Criteria 12 is NL-specific. 13. 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. 14. Subject had a prior pneumonectomy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Amsterdam University Medical Centres, Location AMC, Meibergdreef 9
Amsterdam, 1105 AZ, Netherlands
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Royal Brompton and Harefield NHS Foundation Trust
London, SW3 6NP, United Kingdom
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