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

NCT06423690 | Recruiting

• 1 other identifier: PRC015
• Study Type: interventional
• Target: 15
• Locations: 3 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Safety of the EAS1 System in Lung Tumor Ablation During Procedure

  Accumulative rate of device related Serious Adverse Events (SAEs) during the ablation and up to 48 hours post ablation

  48 hours post procedure

Secondary Outcomes (2)

• Safety of the EAS1 System in Lung Tumor Ablation Throughout Follow Up

  30 days

• Investigator's Ability to Approach and Ablate the Tumor (Technical Success)

  30 days

Other Outcomes (2)

• Investigator's Impression of the Treatment (Investigator's Satisfaction)

  30 days

• Assessment of Immunological Response Following Ablation

  30 days

Study Arms (1)

Treatment Arm - Ablation with EAS1 System

EXPERIMENTAL

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

Device: EAS1 System

Interventions

EAS1 System DEVICE

tumor ablation system in IRE method

Treatment Arm - Ablation with EAS1 System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Snipe Medical: lead

Study Sites (3)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

University Hospital Complex of Salamanca

Salamanca, Spain

RECRUITING

Royal Brompton Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eyal Romem, Dr

  Principal investigator at Meir Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Ben Shlomo

CONTACT

972523212687; emily.benshlomo@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: November 1, 2024
• Primary Completion: May 15, 2025
• Study Completion: July 15, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); IL (1); ES (1)