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Irreversible Electroporation(IRE) For Uterine Cervical Neoplasms | Clinical Trials | Clareo Health

COMPLETEDNA

Irreversible Electroporation(IRE) For Uterine Cervical Neoplasms

Irreversible Electroporation(IRE) For Unresectable Uterine Cervical Neoplasms: Phase I and Phase II Clinical Trial

NCT02430610•Fuda Cancer Hospital, Guangzhou

Summary

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

Detailed Description

By enrolling patients with unresectable Uterine Cervical 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 Uterine Cervical Neoplasms.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

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.

Locations (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, China

Key Dates

Start Date

January 1, 2015

Primary Completion Date

December 1, 2020

Completion Date

February 1, 2021

Last Updated

September 5, 2021

Enrollment

ACTUAL participants

Conditions

Uterine Cervical Neoplasms

Interventions

Irreversible electroporation (IRE)

PROCEDURE

NanoKnife

DEVICE

Video-Based Patient Navigation to Support Cervical Cancer Screening Among Black Women

NCT07011836

Uterine Cervical Neoplasms

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RECRUITINGNA

PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer

NCT05406856

Uterine Cervical NeoplasmsLocally Advanced Cervical Carcinoma

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RECRUITINGPHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Irreversible Electroporation(IRE) For Uterine Cervical Neoplasms

Inclusion Criteria

Exclusion Criteria

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