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

NCT ID: NCT06423690

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-07-15

Brief 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

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm - Ablation with EAS1 System

Ablation of the lung tumor via Irreversible Electroporation (IRE) method, followed by resection of the tumor up to 14 days after the ablation

Group Type: EXPERIMENTAL

EAS1 System

Intervention Type: DEVICE

tumor ablation system in IRE method

Interventions

EAS1 System

tumor ablation system in IRE method

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Snipe Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eyal Romem, Dr

Role: PRINCIPAL_INVESTIGATOR

Principal investigator at Meir Medical Center

Locations

Meir Medical Center

Kfar Saba, , Israel

Site Status: RECRUITING

University Hospital Complex of Salamanca

Salamanca, , Spain

Site Status: RECRUITING

Royal Brompton Hospital

London, , United Kingdom

Site Status: RECRUITING

Countries

Israel; Spain; United Kingdom

Central Contacts

Emily Ben Shlomo

Role: CONTACT

Phone: 972523212687

Email: emily.benshlomo@clalit.org.il

Facility Contacts

Emily Ben Shlomo

Role: primary

Marcelo Jimenez, Dr

Role: primary

Anand Tana

Role: primary

Other Identifiers

PRC015

Identifier Type: -

Identifier Source: org_study_id