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

December 5, 2024 updated by: Snipe Medical

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Arm - Ablation with EAS1 System
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
tumor ablation system in IRE method

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
48 hours post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety of the EAS1 System in Lung Tumor Ablation Throughout Follow Up
Time Frame: 30 days
Rate of device related SAEs during the follow up period
30 days
Investigator's Ability to Approach and Ablate the Tumor (Technical Success)
Time Frame: 30 days
- Technical success, defined as the investigator's ability to access the target tumor and successfully perform the irreversible electroporation, as confirmed by histology analysis
30 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Investigator's Impression of the Treatment (Investigator's Satisfaction)
Time Frame: 30 days
Investigator satisfaction, as determined by completing an internal ease-of-use questionnaire following each procedure. The questionnaire consists of 10 questions, each ranging from 1 (not at all) to 5 (very much). Range of total score is 10-50, where the higher the total score, the more satisfied the investigator is from device use
30 days
Assessment of Immunological Response Following Ablation
Time Frame: 30 days
Immunological response, as determined by change from baseline to 30 day FU in immunological blood markers.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Snipe Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eyal Romem, Dr, Principal investigator at Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRC015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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