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Irreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms | Clinical Trials | Clareo Health

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Irreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms

Irreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms: Phase I and Phase II Clinical Trial

NCT02430779•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 unresectable Renal Pelvic and Ureteral Neoplasms.

Detailed Description

By enrolling patients with unresectable Renal Pelvic and Ureteral Neoplasms 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 unresectable Renal Pelvic and Ureteral Neoplasms.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Renal Pelvic and Ureteral 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.

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

January 1, 2021

Last Updated

September 5, 2021

Enrollment

ACTUAL participants

Conditions

Renal Pelvic and Ureteral Neoplasms

Interventions

rreversible electroporation (IRE)

PROCEDURE

NanoKnife

DEVICE