NCT02430610

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

September 5, 2021

Status Verified

April 1, 2019

Enrollment Period

5.9 years

First QC Date

April 26, 2015

Last Update Submit

September 1, 2021

Conditions

Uterine Cervical Neoplasms

Keywords

irreversible electroporationUnresectable Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Adverse events

    6 month

Secondary Outcomes (4)

  • Voltage (A minimum and maximum range of voltage for safe and effective 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 Uterine Cervical Neoplasms

Procedure: Irreversible electroporation (IRE)Device: NanoKnife

Control

NO INTERVENTION

The patients without treatment

Interventions

Irreversible electroporation (IRE)PROCEDURE

Irreversible Electroportion For Unresectable Uterine Cervical 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:

  • Uterine Cervical 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.

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.

Sponsors & Collaborators

Study Sites (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesInvestigative TechniquesElectrochemical Techniques

Study Officials

  • Lizhi Niu, PhD

    Fuda Cancer Hospital

    STUDY CHAIR

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

Primary Completion

December 1, 2020

Study Completion

February 1, 2021

Last Updated

September 5, 2021

Record last verified: 2019-04

Locations

CN(1)