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Irreversible Electroporation(IRE) For Lung Neoplasms Accompanied by Respiratory Function Insufficiency | Clinical Trials | Clareo Health

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

Irreversible Electroporation(IRE) For Lung Neoplasms Accompanied by Respiratory Function Insufficiency: Phase I and Phase II Clinical Trial

NCT02430753•Fuda Cancer Hospital, Guangzhou

View on ClinicalTrials.gov

Summary

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

Detailed 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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, China

Key Dates

Start Date

January 1, 2015

Primary Completion Date

December 1, 2020

Completion Date

February 1, 2021

Last Updated

September 5, 2021

Enrollment

ACTUAL participants

Conditions

Lung Neoplasms Accompanied by Respiratory Function Insufficiency

Interventions

Irreversible electroporation (IRE)

PROCEDURE

NanoKnife

DEVICE