Actively Recruiting
First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System
Led by Snipe Medical · Updated on 2024-12-10
15
Participants Needed
3
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Able and willing to provide informed consent
- Diagnosed with lung cancer at clinical stages cT1a to cT1c, cN0
- Have at least one pulmonary tumor 30 mm or smaller as confirmed by recent CT or MRI
- Scheduled or eligible for lung tumor resection by a thoracic surgeon
- Able and willing to follow study procedures and visits
- At least 5 mm of nodule-free lung tissue between the tumor and pleura or fissure confirmed by recent CT or MRI
- ECOG performance status 0-1
- Taking stable doses of any other medications for at least four weeks before enrollment
You will not qualify if you...
- Unable to provide informed consent
- Contraindicated for tumor resection surgery
- Life expectancy less than 12 months
- Tumor touching main stem bronchus, main pulmonary vessels, esophagus, or trachea
- Forced Expiratory Volume (FEV1) less than 50%
- Total Lung Capacity (TLC) less than 80% of expected for age
- Diffusing Capacity (DCO) less than 60% of expected
- Oxygen saturation below 88% on room air or needing more than 2 liters per minute oxygen to maintain 92% saturation
- PCO2 equal or above 45 mm/Hg
- High-risk exacerbations (2 or more per year or 1 or more requiring hospitalization)
- Severe emphysema, Bullous Emphysema, or severe COPD (GOLD III/IV)
- Active or prolonged lung or bronchial infection requiring antibiotics within 21 days before screening
- History or current significant bronchiectasis
- Lung Bullae occupying more than one third of the lung targeted for ablation
- Previous surgery in the lung targeted for ablation or major thoracic surgery on that side
- Anticoagulation therapy that cannot be stopped before ablation or bleeding disorders
- Pregnant or breastfeeding, or planning pregnancy during the study
- Highly hypoxemic as judged by the investigator
- Implanted metal or electronic thoracic devices that cannot be removed before the procedure
- Contraindications for bronchoscopy
- Participation in another interventional clinical trial within 30 days before consent
- Any condition that the investigator feels could put the participant at risk from study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Meir Medical Center
Kfar Saba, Israel
Actively Recruiting
2
University Hospital Complex of Salamanca
Salamanca, Spain
Actively Recruiting
3
Royal Brompton Hospital
London, United Kingdom
Actively Recruiting
Research Team
E
Emily Ben Shlomo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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