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Irreversible Electroporation(IRE) For Unresectable Laryngeal Neoplasms (IRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02430675
Recruitment Status : Recruiting
First Posted : April 30, 2015
Last Update Posted : March 29, 2016
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

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

Condition or disease Intervention/treatment Phase
Laryngeal Neoplasms Procedure: Irreversible electroporation (IRE) Device: NanoKnife Phase 1 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irreversible Electroporation(IRE) For Unresectable Laryngeal Neoplasms: Phase I and Phase II Clinical Trial
Study Start Date : January 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: Group A
irreversible electroporation for Unresectable Laryngeal Neoplasms
Procedure: Irreversible electroporation (IRE)
Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.
Other Name: NanoKnife

Device: NanoKnife

Primary Outcome Measures :
  1. Number of participants with Adverse events [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Percentage of lesions that show no sign of recurrence 12 months after IRE [ Time Frame: 12 months ]
  2. 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

  3. Progress free disease (PFS) [ Time Frame: 12 months ]
  4. Overall survival (OS) [ Time Frame: 36 months ]
    Patients will be followed for 36 months after IRE for OS analyzed.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Laryngeal 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02430675

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Contact: Lizhi Niu, PhD

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China, Guangdong
Biological treatment center in Fuda cancer hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Chen Jibing, PhD    +86-18903068207   
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
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Study Chair: Lizhi Niu, PhD Fuda Cancer Hospital

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Responsible Party: Fuda Cancer Hospital, Guangzhou Identifier: NCT02430675     History of Changes
Other Study ID Numbers: Laryngeal Neoplasms-IRE-01
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016

Keywords provided by Fuda Cancer Hospital, Guangzhou:
irreversible electroporation
Unresectable Laryngeal Neoplasms

Additional relevant MeSH terms:
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Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases