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The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Uterine Cervical Neoplasms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRE Group | Experimental | irreversible electroporation for Unresectable Uterine Cervical Neoplasms |
|
| Control | No Intervention | The patients without treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irreversible electroporation (IRE) | Procedure | Irreversible Electroportion For Unresectable Uterine Cervical Neoplasms guide with ultrasound or/and CT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse events | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | A minimum and maximum range of voltage for safe and effective IRE will be |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lizhi Niu, PhD | Fuda Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biological treatment center in Fuda cancer hospital | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D018274 | Electroporation |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
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| NanoKnife | Device |
|
| 3 months |
| Progress free disease (PFS) | 12 months |
| Overall survival (OS) | Patients will be followed for 36 months after IRE for OS analyzed. | 36 months |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |