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

Sponsor: Snipe Medical

NCT ID: NCT06423690

View on ClinicalTrials.gov ↗

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

Lung Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
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

Where Is This Study? (1 UK site)

Royal Brompton Hospital

London, United Kingdom

Recruiting
Site contact (verified)
Pallav Shah, DrPrincipal Investigator

How to Get in Touch

Emily Ben Shlomo

Sponsor contact

CONTACT

972523212687 emily.benshlomo@clalit.org.il
Data sourced from ClinicalTrials.gov · Last verified: 2024-12