Lung CancerNCT06423690
First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System
A study testing EAS1 System in people with Lung Cancer, run by Snipe Medical at 3 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- EAS1 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Nov 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Emily Ben Shlomo, "emily.benshlomo@clalit.org.il" <emily.benshlomo@clalit.org.il>
Eyal Romem, Dr
Spain1 site, 1 recruiting
- Recruiting
University Hospital Complex of Salamanca
Salamanca
Marcelo Jimenez, Dr, +34923291100 ext. 55383, marcelo.jimenez@usal.es
Marcelo Jimenez, Dr.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton Hospital
London
Anand Tana, +44 207 352 8121, A.Tana@rbht.nhs.uk
Pallav Shah, Dr
About this study
Official title: Snipe Medical First In Human Study
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
- Being tested
- EAS1 System
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAS1 SystemDevice
tumor ablation system in IRE method
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: EAS1 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours post procedure
Secondary outcomes (2)
Safety of the EAS1 System in Lung Tumor Ablation Throughout Follow Up
Rate of device related SAEs during the follow up period
Measured: 30 days
Investigator's Ability to Approach and Ablate the Tumor (Technical Success)
- Technical success, defined as the investigator's ability to access the target tumor and successfully perform the irreversible electroporation, as confirmed by histology analysis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Nov 2024
- Primary completion15 May 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Snipe Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eyal Romem, Dr, Principal investigator, Principal investigator at Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423690
- Sponsor's protocol ID
- PRC015
- Status last verified
- Dec 2024
- First submitted
- 16 May 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Snipe Medical First In Human Study
- ClinicalTrials.gov ID
- NCT06423690
- Acronym / sponsor ID
- PRC015
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Snipe MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm - Ablation with EAS1 System | Experimental | Device: EAS1 SystemAblation of the lung tumor via Irreversible Electroporation (IRE) method, followed by resection of the tumor up to 14 days after the ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EAS1 Systemtumor ablation system in IRE method | Device | Treatment Arm - Ablation with EAS1 System |
Primary outcome
Safety of the EAS1 System in Lung Tumor Ablation During Procedure
Time frame: 48 hours post procedure
Accumulative rate of device related Serious Adverse Events (SAEs) during the ablation and up to 48 hours post ablation
2 secondary outcomes
Safety of the EAS1 System in Lung Tumor Ablation Throughout Follow Up
Time frame: 30 days
Investigator's Ability to Approach and Ablate the Tumor (Technical Success)
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eyal Romem, Dr principal investigator
Principal investigator at Meir Medical Center
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EAS1 System in people with Lung Cancer, run by Snipe Medical at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Ben Shlomo (972523212687, emily.benshlomo@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the EAS1 System in Lung Tumor Ablation During Procedure (time frame: 48 hours post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.