An observational study in Lung Cancer, sponsored by Creo Medical Limited. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Creo Medical Limited · Observational
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 35 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Creo Medical Limited is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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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.
The participant may enter the study if ALL of the following apply:
The patient:
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):
Any patient with clinically significant interstitial lung disease in the zone of planned ablation.
Note: Exclusion Criteria 12 is NL-specific.
Patients with a single or multiple soft tissue lung lesions that is medically inoperable or for which the patient has declined surgical resection.
Device: Ablation
Bronchoscopy and microwave ablation of lung nodule
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.
Time frame: 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.
Time frame: Up to 30 days after the ablation procedure.
Secondary Safety Endpoint
Identification of all device-related, procedure related and other adverse events related to bronchoscopic microwave ablation interventions using the AB1 system.
Time frame: 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.
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)
Patients will rate their responses from 1 to 4 on a Likert Scale (1 being "not at all" and 4 being "very much").
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Up to 12 months
Secondary Effectiveness Outcomes - Procedural Time
Procedural time to be captured in the electronic case report form (eCRF).
Time frame: 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".
Time frame: Up to 1 day post ablation procedure.
Plan to share: Undecided — Single site
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This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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