Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms
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|ClinicalTrials.gov Identifier: NCT02425059|
Recruitment Status : Recruiting
First Posted : April 23, 2015
Last Update Posted : March 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Rectal Neoplasms||Procedure: Irreversible electroporation (IRE) Device: NanoKnife||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms: Phase I and Phase II Clinical Trial|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2020|
Experimental: IRE Group
irreversible electroporation for Unresectable Rectal Neoplasms
Procedure: Irreversible electroporation (IRE)
Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.
- Number of participants with Adverse events [ Time Frame: 6 month ]
- Percentage of lesions that show no sign of recurrence 12 months after IRE [ Time Frame: 12 months ]
- A minimum and maximum range of voltage for safe and effective IRE [ Time Frame: 3 months ]A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.
- Progress free disease (PFS) [ Time Frame: 12 months ]
- Overall survival (OS) [ Time Frame: 36 mouths ]Patients will be followed for 36 months after IRE for OS analyzed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425059
|Contact: Lizhi Niu, PhDfirstname.lastname@example.org|
|Biological treatment center in Fuda cancer hospital||Recruiting|
|Guangzhou, Guangdong, China, 510000|
|Contact: Chen Jibing, PhD +86-18903068207 email@example.com|
|Study Chair:||Lizhi Niu, PhD||Fuda Cancer Hospital|