Galvanize Aliya® EX Pulsed Electric Field (PEF) Treat and Resect Study
ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGalvanize Therapeutics, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presence of at least one lesion in the lung measuring ≥ 1.5 cm and ≤ 4 cm diameter by computed tomography (CT) size estimate deemed suitable for PEF ablation per institutional guidelines.
High probability of malignancy as determined by the investigator.
Patient has been deemed a candidate for definitive lung tissue resection per institutional SOC.
Patient is, in the opinion of the Principal Investigator (PI), able to adhere to and undergo the PEF and surgical procedures.
Disqualifiers
Patient requires neoadjuvant therapy for the disease for which surgical resection is intended.
Patient is receiving concurrent cancer treatment (e.g., external beam radiation therapy, brachytherapy, chemotherapy, targeted therapy, immunotherapy, other focal therapy).
Patient has received effective treatment for the target lesion in the last two years prior to the date of consent.
Patient has undergone prior pneumonectomy.
Trial design
Design model
Single group
Treatments tested in this trial
Aliya Pulsed Electric Field (PEF)
DevicePulsed electric field treatment using the Aliya EX System
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device and Procedure related serious adverse event rate
Rate of study device-related and/or PEF procedure-related serious adverse events (SAEs)
Time frame
From the PEF procedure through surgical resection (approximately 30 days later)2
Technical success
The frequency with which the clinician can access the target lesion and deliver PEF energy
Time frame
Intra-proceduralSponsors and contacts
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Source ClinicalTrials.gov