NCT07487064

Galvanize Aliya® EX Pulsed Electric Field (PEF) Treat and Resect Study

A Targeted Ablation and Resection Study With Galvanize Aliya® EX Pulsed Electric Field (PEF) Technology

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Galvanize Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-arm, non-randomized, single-center, open-label, treat and resect study following patients through surgical resection. The study is designed to evaluate the safety and feasibility of the Aliya EX System for the ablation of pulmonary lesions using pulsed electric field (PEF) energy delivery. The study is intended for adult patients with suspected or confirmed pulmonary malignant lesion(s) ≥1.5 cm to ≤4 cm whom are surgical candidates and have not received treatment for the index tumor in the last two years.

Detailed description

This study is to evaluate the safety and technical success of delivering Aliya® pulsed electric fields (Aliya PEF) for ablation of pulmonary lesions in patients with suspected or confirmed malignancy, prior to planned surgical resection. Treatment may be delivered via either an endoluminal (bronchoscopic) or percutaneous approach at the discretion of the clinical investigator utilizing two available device configurations: Bronchoscopic approach: Aliya® EX Generator, the INUMI Flex Needle and the Aliya® Electrode. Percutaneous approach: Aliya® EX Generator, the Aliya® Needle and the Aliya® Electrode. The study will enroll and treat up to 25 adult patients with suspected or confirmed pulmonary malignant lesion(s) in patients whom are surgical candidates at 1 clinical site.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Aliya Pulsed Electric Field (PEF)	Pulsed electric field treatment using the Aliya EX System

Timeline

• Start date: 2026-03-13
• Primary completion: 2027-01-31
• Completion: 2027-02-28
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: Hong Kong