Uterine Cervical Neoplasms
Conditions
Keywords
irreversible electroporation, Unresectable Uterine Cervical Neoplasms
Brief 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.
Interventions
PROCEDUREIrreversible electroporation (IRE)
Irreversible Electroportion For Unresectable Uterine Cervical Neoplasms guide with ultrasound or/and CT.
DEVICENanoKnife
Sponsors
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Adverse events | 6 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | A minimum and maximum range of voltage for safe and effective IRE will be |
| Progress free disease (PFS) | 12 months | — |
| Overall survival (OS) | 36 months | Patients will be followed for 36 months after IRE for OS analyzed. |
Countries
China
Outcome results
None listed