NCT05786625

Bronchoscopic Microwave Ablation of Lung Tissue

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Creo Medical Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Ablation	Bronchoscopy and microwave ablation of lung nodule

Timeline

• Start date: 2023-05-04
• Primary completion: 2025-11-26
• Completion: 2026-12-01
• First posted: 2023-03-27
• Last updated: 2026-02-02

Locations

2 sites across 2 countries: Netherlands, United Kingdom