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The goal of this clinical trial is to verify the safety and clinical benefit of pulsed electric field (PEF) treatment of advanced or unresectable esophageal squamous cell carcinoma patients.
The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEF treatment | Experimental | One group prospective clinical |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEF treatment | Device | PEF energy delivery via endoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of PEF treatment | evaluate the rate of AEs/SAEs associated with instrument-related/or surgical procedures within 30 days of PEF treatment | 1 month |
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Inclusion Criteria:
Aged 20 years or older when signing the informed consent form.
Able to provide written informed consent, and understand and follow the study requirements and assessment schedule.
Screening period tumor patients ECOG performance status score of 0 or 1.
Laboratory test data within 7 days before the planned PEF treatment date during the screening period must meet the following standards.
Females of childbearing potential must have a negative serum pregnancy test at screening and be willing to undergo additional pregnancy testing during the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Xu | Contact | +86 021 52230973 | info@energenxmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |