hilus pulmonis -IRE-01

About this trial

Last updated 4 years ago

Completed

Interventional

N/A

All

Ended 4 years ago

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for Hilus Pumonis Neoplasms.

Inclusion Criteria

- Hilus Pumonis Neoplasms diagnosed by positive biopsy or non-invasive criteria,

- Not suitable for surgical resection,

- Eastern Cooperative Oncology Group (ECOG) score of 0-1,

- A prothrombin time ratio > 50%,

- Platelet count > 80x10^9/L,

- Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,

- Able to comprehend and willing to sign the written informed consent form (ICF),

- Have a life expectancy of at least 3 months.

Exclusion Criteria

- Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,

- Any active implanted device (eg Pacemaker),

- Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,

- Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,

- Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.