Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pulsed electric field treatment using the Aliya System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Patients participating in the treatment group will undergo pulsed electric field (PEF) treatment of a single NSCLC nodule measuring 1 to 4 cm by CT, using the Aliya System. The treatment may be performed endoluminally in conjunction with a diagnostic bronchoscopy, or percutaneously.
- interventionNames
- Device: Pulsed electric field treatment using the Aliya System
- type
- NO_INTERVENTION
- label
- Control
- description
- Patients declining to participate in the treatment arm may self-select to participate in an observational control arm.
Primary outcomes (1)
- measure
- Device and Procedure related serious adverse event rate
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Presence of solitary NSCLC nodule 8th ed. stage IA2, IA3 or IB * Nodule measuring \> 1 cm and ≤4 cm diameter by CT size estimate (e.g. T1b, T1c, T2a), with a minimum 1 cm solid component * High pre-procedure probability of malignancy as determined by the investigator * Patient has been evaluated by a thoracic surgeon and deemed a candidate for definitive lung tissue resection * Patient is, in the opinion of the principal investigator, able to adhere to and undergo bronchoscopy, surgical procedure and post-treatment care Exclusion Criteria: * Additional pulmonary nodules requiring intervention * Patient is receiving concurrent cancer treatment (e.g. external beam radiation therapy, brachytherapy, chemotherapy, targeted therapy, immunotherapy, other focal therapy) or has received treatment for the index tumor in the last two years * Patient has implanted lung devices or electronic devices * Patient has N1 disease * Patient is immune compromised or receiving immune modulating medication * Recurrent NSCLC within 2 years of initial definitive treatment * Previous checkpoint inhibitor treatment for another cancer
References
Publications (0)
Data not yet available