Posted in Research

History of Changes for Study: NCT02430701

 October 26, 2021

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Study Identification
Unique Protocol ID: Esophageal Neoplasms -IRE-01
Brief Title: Irreversible Electroporation(IRE) For Unresectable Esophageal Neoplasms (IRE)
Official Title: Irreversible Electroporation(IRE) For Unresectable Esophageal Neoplasms: Phase I and Phase II Clinical Trial
Secondary IDs:
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Study Status
Record Verification: April 2019
Overall Status: Completed
Study Start: January 1, 2015
Primary Completion: December 1, 2020 [Actual]
Study Completion: April 1, 2021 [Actual]
First Submitted: April 26, 2015
First Submitted that
Met QC Criteria:		 April 29, 2015
First Posted: April 30, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:		 September 1, 2021
Last Update Posted: September 5, 2021 [Actual]
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Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
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Study Description
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Esophageal Neoplasms.
Detailed Description: By enrolling patients with unresectable Esophageal 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 Esophageal Neoplasms.
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Conditions
Conditions: Esophageal Neoplasms
Keywords: irreversible electroporation
Unresectable Esophageal Neoplasms
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Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Investigator)
Allocation: Randomized
Enrollment: 30 [Actual]
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Arms and Interventions
Arms Assigned Interventions
Experimental: IRE Group

irreversible electroporation for Unresectable Esophageal Neoplasms

 Procedure: Irreversible electroporation (IRE)

Irreversible Electroportion For Unresectable Esophageal Neoplasms guide with ultrasound or/and CT.

Device: NanoKnife

No Intervention: Control

The patients without treatment
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Outcome Measures
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.

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Eligibility
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Esophageal 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 > 80×10^9/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.
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IPDSharing
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References
Citations:
Links:
Available IPD/Information:

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