NCT06689488

Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Creo Medical Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of this study is to characterise the clinical safety and performance of the Creo Medical MicroBlate™ Flex AB1 instrument in patients with pathologically confirmed malignancy eligible for surgical resection of their nodule, receiving bronchoscopic ablation prior to surgery.

Detailed description

This is a post-market, prospective, single-arm, multicentre, open-label, non-randomised study which will enrol up to 30 subjects in total (plus replacements if required due to drop out). Prospective patients must have a histopathological-confirmed malignant lung lesion and be candidates for surgical resection. 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. The study consists of two (2) stages (Stage A and Stage B). Stage A consists of the ablation and surgical resection being performed concurrently on Day 0 within a single procedure. Stage B consists of the ablation and the surgical resection being performed in separate procedures. The surgical resection will occur between Day 7 and Day 21, post-ablation, inclusive of those days. The aim is to follow local guidelines for treatment of lung cancer. Patients undergoing Stage A will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study). Patients undergoing Stage B will have evaluations at follow-up visits conducted at 7 (+/-3) days (via phone call) post ablation and prior to the surgical resection procedure. Stage B patients will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study).

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Ablation	Bronchoscopy and microwave ablation prior to surgical resection.

Timeline

• Start date: 2025-06-17
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2024-11-14
• Last updated: 2025-06-26

Locations

1 site across 1 country: Netherlands