NCT02430597

Completed

Irreversible Electroporation(IRE) For Unresectable Hilus Pul...

Fuda Cancer Hospital, Guangzhou Source

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Other study identifiers

Sponsor study identifier

hilus pulmonis -IRE-01

Study Type

interventional

Actual enrollment (reported)

30

Locations

1 country

Sites

1

Timeline

Study Start

January 1, 2015

Actual (reported)

Primary Completion

December 1, 2020

Actual (reported)

Study Completion

March 1, 2021

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 30 participants
Study completion date: March 1, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 1, 2015
Actual (reported)
First Submitted
April 26, 2015
Actual (reported)
First Posted
April 30, 2015
Actual (reported)
Primary Completion
December 1, 2020
Actual (reported)
Study Completion
March 1, 2021
Actual (reported)

Last Updated: September 5, 2021
Status Verified: April 2019
Last Update Submitted: September 1, 2021

Conditions

Hilus Pulmonary Neoplasms

Keywords

irreversible electroporationHilus Pulmonary Neoplasms

Outcome Measures

Primary Outcomes (1)

Number of participants with Adverse events
6 month

Secondary Outcomes (4)

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
3 months
Progress free disease (PFS)
12 months
Overall survival (OS)
36 months

Study Arms (2)

IRE Group

EXPERIMENTAL

irreversible electroporation for Unresectable Hilus Pulmonis Neoplasms

Procedure: Irreversible electroporation (IRE)Device: NanoKnife

Control

NO INTERVENTION

The patients without treatment

Interventions

Irreversible electroporation (IRE)Procedure

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

Also known as: NanoKnife

IRE Group

NanoKnifeDevice

IRE Group

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Hilus Pumonis Neoplasms diagnosed by positive biopsy or non-invasive criteria,
Not suitable for surgical resection,

Sponsors & Collaborators

Fuda Cancer Hospital, Guangzhou
Otherlead

Study Sites (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

MeSH Terms

Interventions

Electroporation

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesInvestigative TechniquesElectrochemical Techniques

Study Officials

Lizhi Niu, PhD
Fuda Cancer Hospital
STUDY CHAIR

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 26, 2015

First Posted

April 30, 2015

Study Start

January 1, 2015

Actual (reported)

NCT02430675

Irreversible Electroporation(IRE) For Unresectable Laryngeal Neoplasms

Not ApplicableCompleted

NCT02430688

Irreversible Electroporation(IRE) For Unresectable Extremities Neoplasms

Not ApplicableCompleted

NCT02430649

Irreversible Electroporation(IRE) For Unresectable Prostatic Neoplasms

Not ApplicableWithdrawn

NCT02430623

Irreversible Electroporation(IRE) For Unresectable Urinary Bladder Neoplasms

Not ApplicableCompleted

NCT02430610

Irreversible Electroporation(IRE) For Uterine Cervical Neoplasms

Not ApplicableCompleted

NCT02430662

Irreversible Electroporation(IRE) For Unresectable Gallbladder Neoplasms

Not ApplicableCompleted

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

December 1, 2020

Actual (reported)

Study Completion

March 1, 2021

Actual (reported)

Last Updated

September 5, 2021

Record last verified: 2019-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02430597
Data provider: ClinicalTrials.gov
Source updated: 2021-09-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:32 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

IRE Group

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations