NCT04732520

Feasibility Study of the Aliya System in the Treatment of Early Stage Non-small Cell Lung Cancer

The Galvanize Therapeutics Early Stage, Non-Small Cell Lung Cancer, Treat and Resect Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Galvanize Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, two-arm, non-randomized, concurrently controlled, multi-center, open-label, treat and resect study following patients to 1 year. The study is designed to evaluate the safety and feasibility of the Aliya System for the ablation of solid tumors using pulsed electric field (PEF) energy delivery. The study is intended for adult patients with suspected or confirmed NSCLC 8th ed. Stage IA2, IA3 or IB (\>1 to ≤4 cm solitary lesion) who 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 initial feasibility of Pulsed Electric Field (PEF) treatment of NSCLC tumors prior to 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: * Endoluminal: Galvanize Aliya System with commercially available TBNA Needle (e.g., PeriView FLEX) and RF probe electrode * Percutaneous: Galvanize Aliya System with compatible commercially available RF needle and RF probe electrode The study will enroll and treat up to 30 adult patients with early stage NSCLC at up to 5 clinical sites. Patients meeting all eligibility criteria who elect not to undergo the PEF treatment will be offered the opportunity to participate in a concurrent control arm. Up to 10 patients will be included in the control group. A total of up to 40 patients will be included in the study.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DEVICE	Pulsed electric field treatment using the Aliya System	pulsed electric field treatment of a single NSCLC tumor

Timeline

• Start date: 2021-03-31
• Primary completion: 2023-02-13
• Completion: 2024-02-13
• First posted: 2021-02-01
• Last updated: 2024-07-19

Locations

4 sites across 3 countries: Hong Kong, Netherlands, Spain

Regulatory

• FDA-regulated device study