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This registry aims to assess real-world long-term disease outcomes for patients treated using reversible electroporation and a chemotherapeutic or calcium; in particular tumour response rates and recurrence rates. The study also aims to characterise side effects and the occurrence of Adverse Events and their relationship to the treatment.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (CTCAE) | Safety evaluation will be performed via continuous assessment of safety parameters by reviewing events as they arise. The investigation will be put on hold if unacceptable safety issues are outstanding. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated and graded according to Common Terminology Criteria for Adverse Events (CTCAE) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response Evaluation Criteria in Solid Tumours (RECIST) | A response evaluation will be conducted at standard of care follow up | 3 months, 12 months, 3 years, 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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This study is a single arm, observational medical device registry designed to establish the efficacy and safety of treating solid tumours with reversible electroporation. ePORE, CUTIS and EndoVE are CE marked and are currently being used in the treatment of patients with solid tumours. This medical device registry will enable the collection of anonymised data which will enable the analysis and publication of high quality data to continuously support the efficacy and safety of these devices.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SEAN H KINSELLA | Contact | +353 91 442 498 | sean@mirai-medical.com | |
| Declan Soden | Contact | declan@mirai-medical.com |
| Name | Affiliation | Role |
|---|---|---|
| SEAN H Kinsella | Mirai Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal London Hospital | Recruiting | London | E1 1FR | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 29, 2021 | Jun 10, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| D004067 |
| Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |