Irreversible Electroporation(IRE) For Lung Neoplasms Accompanied by Respiratory Function Insufficiency

Fuda Cancer Hospital, Guangzhou

Status: Completed

Conditions: Lung Neoplasms Accompanied by Respiratory Function Insufficiency

Treatments: Device: NanoKnife; Procedure: Irreversible electroporation (IRE)

Study type: Interventional

Funder types: Other

Identifiers

NCT02430753

lung fuction insuf-IRE-01

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for Lung Neoplasms accompanied by Respiratory Function Insufficiency.

Full description

By enrolling patients with Lung Neoplasms accompanied by Respiratory Function Insufficiency adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for Lung Neoplasms accompanied by Respiratory Function Insufficiency.

Enrollment: 30 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Lung Neoplasms Accompanied by Respiratory Function Insufficiency 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

IRE Group

Experimental group

Description:

irreversible electroporation for Lung Neoplasms accompanied by Respiratory Function Insufficiency

Treatment:

Procedure: Irreversible electroporation (IRE)

Device: NanoKnife

Control

No Intervention group

Description:

The patients without treatment