NCT04732520Completed
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 · Last updated 19 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 28 Jan 2021
- Start date
- Mar 2021
- Primary completion date
- Feb 2023
- Lead sponsor
- Galvanize Therapeutics, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT04732520
What you commit to
- Study type: Interventional
- Participants enrolled: 47
- From Mar 2021 to the primary completion date, Feb 2023
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 is immune compromised or receiving immune modulating medication
- Previous checkpoint inhibitor treatment for another cancer
Other illness
- Patient has N1 disease
Other
- Additional pulmonary nodules requiring intervention
- Patient has implanted lung devices or electronic devices
- Recurrent NSCLC within 2 years of initial definitive treatment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundacion Instituto de Investigation Sanitaria de la Fundacion Jimenez Diaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.