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Bronchoscopic Microwave Ablation of Lung Tissue | Clinical Trials | Clareo Health

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Bronchoscopic Microwave Ablation of Lung Tissue

Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue

NCT05786625•Creo Medical Limited

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•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.
+8 more criteria

Locations (2)

Amsterdam University Medical Centres, Location AMC, Meibergdreef 9

Amsterdam, Netherlands

Royal Brompton and Harefield NHS Foundation Trust

London, United Kingdom

Key Dates

Start Date

May 4, 2023

Primary Completion Date

November 26, 2025

Completion Date

December 1, 2026

Last Updated

February 2, 2026

Enrollment

ACTUAL participants

Conditions

Lung Cancer

Interventions

Ablation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bronchoscopic Microwave Ablation of Lung Tissue

Inclusion Criteria

Exclusion Criteria

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