Irreversible Electroporation(IRE) For Unresectable Extremities Neoplasms

F

Fuda Cancer Hospital, Guangzhou

Status

Completed

Conditions

Extremities Neoplasms

Treatments

Procedure: Irreversible electroporation (IRE)
Device: NanoKnife

Study type

Interventional

Funder types

Other

Identifiers

NCT02430688
Extremities Neoplasms -IRE-01

Details and patient eligibility

About

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

Full description

By enrolling patients with unresectable Extremites 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 Extremities Neoplasms.

Enrollment

30 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Extremities 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

IRE Group
Experimental group
Description:
irreversible electroporation for Unresectable Extremities Neoplasms
Treatment:
Device: NanoKnife
Procedure: Irreversible electroporation (IRE)
Control
No Intervention group
Description:
The patients without treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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