Assessing the safety and performance of the EAS1 System for lung cancer treatment
Snipe Medical First In Human Study
This study is testing a new treatment called the EAS1 System that uses a special technique to help remove lung cancer in adults who are eligible for surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Snipe Medical Industry-sponsored |
| Locations | 3 sites (Kfar Saba and 2 other locations) |
| Trial ID | NCT06423690 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, open-label, multi-center, single-arm trial designed to evaluate the safety and initial performance of the EAS1 System, which utilizes Irreversible Electroporation (IRE) for the ablation of lung cancer. It targets adult patients with specific stages of lung cancer who are eligible for tumor resection. Participants will undergo treatment with the EAS1 System, and their outcomes will be monitored to assess the effectiveness and safety of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of lung cancer at specific stages who are eligible for tumor resection.
Not a fit: Patients who are unable to provide informed consent or have more advanced stages of lung cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with lung cancer that may improve surgical outcomes.
How similar studies have performed: While this approach is innovative, similar studies using Irreversible Electroporation for other cancers have shown promise, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult male and female subjects (age ≥18 years at the date of informed consent signature) * Subject is capable and willing to provide an informed consent * Subjects with a known diagnosis of lung cancer at cT1a-T1c, cN0 stages * At least one pulmonary tumor (primary or metastasis) ≤ 30 mm in maximal diameter, as confirmed by the latest standard of care imaging (CT/MRI), performed preferably up to 30 days prior to screening * Subjects who are scheduled or deemed eligible by a thoracic surgeon for lung tumor resection * Subject is able and willing to comply with the study procedures and visits * There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure, as confirmed by the latest standard of care imaging (CT/MRI), performed preferably up to 30 days prior to screening * ECOG 0-1 * Stable doses of concomitant medications for at least four (4) weeks prior to enrollment Exclusion Criteria: * An inability to provide informed consent * Subjects with contraindication for tumor resection * Subjects with life expectancy \<12 months * Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea * Subjects with Forced Expiratory Volume (FEV1) \<50% * Total Lung Capacity (TLC)\< 80% of expected for age * Diffusing Capacity (DCO) \< 60% of expected * Oxygen saturation in free air of \<88%, or requiring more than 2 l/min oxygen to achieve saturation of 92% * PCO2 of ≥ 45mm/Hg * Subjects in exacerbations group E (high risk; ≥2 exacerbations per year or ≥1 requiring hospitalization and any level of symptoms) * Severe emphysema, Bullous Emphysema or chronic obstructive pulmonary disease (COPD) (GOLD III/IV) * Active and/or prolonged lung or bronchi infection, required an antibiotic treatment up to 21 days prior to screening and for more than 10 days of treatment * Known history or current evidence of a significant bronchiectasis * Evidence of lung Bullae the occupies more than one third of the lung intended for ablation * Previous surgery in the lung intended for ablation; thoracic major surgery at the side intended for ablation * Anticoagulation treatment that cannot be discontinued prior to the ablation, or a bleeding diathesis or platelets \<100 )K/µl) * Pregnant or breastfeeding female subjects or female subjects who plan pregnancy during participation in the study * Highly hypoxemic patients, according to investigator's discretion * Subjects with implanted metal or electronic thoracic devices objects (such as pacemaker) that cannot be removed prior to procedure * Subjects with contraindication for bronchoscopy * Participation in any other interventional clinical trial with medication, medical device and/or supplements within 30 days prior to informed consent signature * Any subject who, at the discretion of the investigator, may be jeopardized by study participation
Where this trial is running
Kfar Saba and 2 other locations
- Meir Medical Center — Kfar Saba, Israel (Recruiting)
- University Hospital Complex of Salamanca — Salamanca, Spain (Recruiting)
- Royal Brompton Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Eyal Romem, Dr — Principal investigator at Meir Medical Center
- Study coordinator: Emily Ben Shlomo
- Email: emily.benshlomo@clalit.org.il
- Phone: 972523212687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.