NCT02567734

Brief Summary

Irreversible electroporation (IRE) is an emerging nonthermal focal ablation technique that uses a series of short but intense electric pulses delivered by NanoKnife generator through paired electrodes into a targeted region of tissue, inducing the cells death by apoptosis through irreversibly disrupting cellular membrane integrity. This study aimed to investigate the safety and efficacy of CT-guided percutaneous irreversible electroporation（IRE） in the treatment of patients with locally advanced tumors in different anatomical position.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

December 28, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

September 28, 2015

Last Update Submit

December 24, 2015

Conditions

NeoplasmsCarcinoma

Keywords

irreversible electroporationablationneoplasmscancercarcinomaNanoKnifeAblation Techniques

Outcome Measures

Primary Outcomes (1)

  • effective rate of IRE ablation

    The procedure-related result will be assess by the size，blood supply，metabolism of the tumors. The changes of blood test are also considerable.

    up to 12 months after the procedures

Secondary Outcomes (2)

  • 1-year survival rates

    up to 12 months after the procedures

  • complication rate

    During the procedure or up to 12 months after the ablation procedure

Study Arms (1)

Irreversible electroporation

EXPERIMENTAL

In this group，eligible patients were selected to receive the CT-guided percutaneous irreversible electroporation ablation.

Procedure: CT-guided percutaneous irreversible electroporation

Interventions

CT-guided percutaneous irreversible electroporationPROCEDURE

Patients undergo the irreversible electroporation ablation that induce protracted cell death by apoptosis through cell membrane perforation.All these procedures will be performed under the guide of Big bore multislice spiral CT scanning system.

Also known as: NanoKnife
Irreversible electroporation

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed locally advanced solid tumor.
  • Unresectable tumors or the patient refused surgical therapy.
  • Patients in good health conditions can receive general anesthesia.
  • Patients with good compliance can cooperate with doctors for related tests and the regular follow-up.

You may not qualify if:

  • Targeted tissues that metallic wallstents or metallics were implanted.
  • With heart pacemaker or be allergic to contrast medium that can not have related imaging examinations.
  • With bleeding and psychiatric disorders.
  • Severe arrhythmia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese PLA General Hospital

Beijing, 100853, China

Location

MeSH Terms

Conditions

NeoplasmsCarcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Yueyong Xiao

    The Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the Department

Study Record Dates

First Submitted

September 28, 2015

First Posted

October 5, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

December 28, 2015

Record last verified: 2015-10

Locations

CN(1)