Clinical Trial: Irreversible Electroporation(IRE) For Unresectable Laryngeal Neoplasms

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Irreversible Electroporation(IRE) For Unresectable Laryngeal Neoplasms: Phase I and Phase II Clinical Trial

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

Detailed Summary: By enrolling patients with unresectable Laryngeal 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 Laryngeal Neoplasms.
Sponsor: Fuda Cancer Hospital, Guangzhou

Current Primary Outcome: Number of participants with Adverse events [ Time Frame: 6 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of lesions that show no sign of recurrence 12 months after IRE [ Time Frame: 12 months ]
  • A minimum and maximum range of voltage for safe and effective IRE [ Time Frame: 3 months ]
    A minimum and maximum range of voltage for safe and effective IRE will be
  • Progress free disease (PFS) [ Time Frame: 12 months ]
  • Overall survival (OS) [ Time Frame: 36 months ]
    Patients will be followed for 36 months after IRE for OS analyzed.


Original Secondary Outcome: Same as current

Information By: Fuda Cancer Hospital, Guangzhou

Dates:
Date Received: April 26, 2015
Date Started: January 2015
Date Completion: January 2020
Last Updated: March 27, 2016
Last Verified: March 2016