Irreversible Electroporation(IRE) For Unresectable Extrem... | NCT02430688

Studies
Irreversible Electroporation(IRE) For Unresectable Extremities Neoplasms

NCT02430688

Sponsor

Fuda Cancer Hospital, Guangzhou

Status

Completed

Last Update Posted

Sep 5, 2021Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Extremities Neoplasms

Interventions

Irreversible electroporation (IRE)
NanoKnife

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Feb 1, 2021Actual

First Submitted Date

Apr 26, 2015

First Submission Date that Met QC Criteria

Apr 29, 2015

First Posted Date

Apr 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2021

Last Update Posted Date

Sep 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Irreversible electroporation (IRE)	Procedure		IRE Group	NanoKnife
NanoKnife

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with Adverse events		6 month

Secondary Outcomes

Measure	Description	Time Frame
Percentage of lesions that show no sign of recurrence 12 months after IRE		12 months
A minimum and maximum range of voltage for safe and effective IRE	A minimum and maximum range of voltage for safe and effective IRE will be

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Lizhi Niu, PhD	Fuda Cancer Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Biological treatment center in Fuda cancer hospital		Guangzhou	Guangdong	510000	China

Intervention Browse Module

MeSH Terms

ID	Term
D018274	Electroporation

Ancestor Terms

ID	Term
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D008919	Investigative Techniques
D055664	Electrochemical Techniques

Browse Leaves

Not provided

Browse Branches

Not provided