First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System

Trial Title: First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System

NCT ID: NCT06423690

Condition: Lung Cancer

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: EAS1 System
Description: tumor ablation system in IRE method
Arm group label: Treatment Arm - Ablation with EAS1 System

Summary: A Prospective, open label, multi center, single arm, First in Human study to assess the safety and initial performance of EAS1 system for Irreversible Electroporation (IRE) ablation of lung cancer in subjects eligible for tumor resection

Criteria for eligibility:
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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Meir Medical Center

Address:
City: Kfar Saba
Country: Israel

Contact:
Last name: Emily Ben Shlomo
Email: "emily.benshlomo@clalit.org.il"

Investigator:
Last name: Eyal Romem, Dr
Email: Principal Investigator

Facility:
Name: University Hospital Complex of Salamanca

Address:
City: Salamanca
Country: Spain

Contact:
Last name: Marcelo Jimenez, Dr

Phone: +34923291100

Phone ext: 55383
Email: marcelo.jimenez@usal.es

Investigator:
Last name: Marcelo Jimenez, Dr.
Email: Principal Investigator

Facility:
Name: Royal Brompton Hospital

Address:
City: London
Country: United Kingdom

Contact:
Last name: Anand Tana

Phone: +44 207 352 8121
Email: A.Tana@rbht.nhs.uk

Investigator:
Last name: Pallav Shah, Dr
Email: Principal Investigator

Start date: July 1, 2024

Completion date: February 15, 2025

Lead sponsor:
Agency: Snipe Medical
Agency class: Industry

Source: Snipe Medical

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06423690