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Bronchoscopic Microwave Ablation of Lung Tissue — AB1MALT  

Lung Cancer Clinical Trial

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

Clinical 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.

Clinical Trial Description

This is a post-market, prospective, single-arm, multicentre, non-randomized, observational study which will enrol up to 32 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05786625
Study type Observational
Source Creo Medical Limited
Contact Patrick Burn
Phone +44 1291 606 005
Email Patrick.Burn@creomedical.com
Status Recruiting
Phase
Start date May 4, 2023
Completion date March 2025
View Details
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