At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- EAS1 System (device)
- How long the study runs
- Study runs about 8 months (dates as stated)
- About the drug or intervention
- EAS1 System — device: tumor ablation system in IRE method
- Patient visit burden
- Not specified by the sponsor
In plain English
This is a first-in-human UK study testing the safety and early performance of a new device called the EAS1 System in adults with early-stage lung cancer (small tumours, 30 mm or less). It is funded by Snipe Medical. People taking part must already be scheduled or considered suitable for surgery to remove their lung tumour.
Who can take part
- Adults aged 18 or over who can give informed consent
- Have lung cancer at an early stage (cT1a-T1c, cN0)
- Have at least one lung tumour (primary or spread) 30 mm or smaller, confirmed by a recent scan (CT or MRI)
- Already scheduled or judged fit by a chest surgeon for surgery to remove the lung tumour
- At least 5 mm of healthy lung between the tumour and the lung lining or fissure, seen on a recent scan
- Good daily functioning (ECOG score 0-1, meaning fully active or restricted only in strenuous activity)
- On stable doses of other medicines for at least 4 weeks before joining
- Able and willing to follow the study visits and procedures
Who may not be able to
- Unable to give informed consent, or not fit for tumour removal surgery
- Life expectancy under 12 months
- Tumour touching the main airway (bronchus), major lung blood vessels, gullet (esophagus) or windpipe (trachea)
- Poor lung function: FEV1 (breathing test) below 50%, total lung capacity below 80% of expected, or diffusing capacity below 60% of expected
- Low oxygen levels: below 88% in room air, or needing more than 2 litres per minute of oxygen to reach 92%
- High-risk COPD (chronic obstructive pulmonary disease, GOLD stage III/IV), severe or bullous emphysema, or frequent flare-ups (2 or more per year, or 1 needing hospital stay)
- Active or long-lasting lung or airway infection needing antibiotics in the past 21 days (or more than 10 days of treatment)
- History of significant bronchiectasis (widened airways)
- Large air pockets (bullae) taking up more than a third of the lung to be treated
- Previous lung surgery on the side to be treated, or major chest surgery on that side
- Blood-thinning medicine that cannot be stopped before treatment, a bleeding disorder, or low platelets (below 100 K/µl)
- Pregnant or breastfeeding women, or women planning pregnancy during the study
- Very low blood oxygen, in the researcher's judgement
- Metal or electronic devices in the chest (such as a pacemaker) that cannot be removed
- Not able to have a bronchoscopy (a camera test of the airways)
- Taking part in another trial of a medicine, device or supplement in the past 30 days
- Anyone the researcher thinks could be harmed by taking part
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and exactly what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 15
- Started
- 2024-11-01
- Last checked
- 2024-12
Plain English Summary
What is this study?
- • Testing a new treatment for lung cancer
- • NA - 15 participants
- • 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
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with lung cancer
Where?
- • London - Royal Brompton Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 80 Years
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
What the study is looking for
- ✓Adult male and female subjects (age ≥18 years at the date of agreement to take part signature)
- ✓Subject is capable and willing to provide an agreement to take part
- ✓Subjects with a known diagnosis of lung cancer at cT1a-T1c, cN0 stages
- ✓At least one lung tumor (primary or metastasis) ≤ 30 mm in maximal diameter, as confirmed by the latest...
- ✓Subjects who are scheduled or deemed eligible by a thoracic surgeon for lung tumor resection
Who cannot take part
- ✗An inability to provide agreement to take part
- ✗Subjects with safety concern for tumor resection
- ✗Subjects with life expectancy \<12 months
- ✗Target nodule is abutting main stem bronchus, main lung vasculature, esophagus and/or trachea
- ✗Subjects with Forced Expiratory Volume (FEV1) \<50%
See the full criteria
Where Is This Study? (1 UK site)
Royal Brompton Hospital
London, United Kingdom
How to Get in Touch
Emily Ben Shlomo
Sponsor contactCONTACT
