PIONEER 1.0

• Research type

  Research Database

• IRAS ID

  292649

• Contact name

  Sean Kinsella

• Contact email

  sean@mirai-medical.com

• Research summary

  Electroporation for cancer treatment real world registry

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  21/YH/0082

• Date of REC Opinion

  20 May 2021

• REC opinion

  Further Information Favourable Opinion

• Data collection arrangements

  We will collect the following information;
  - Diagnosis Information
  o Type of Cancer
  o Size of Main Lesion
  o Location of Main Lesion
  o Previous Treatments – if any.
  - Treatment Information
  o Anaesthetic Used
  o Therapeutic Used (Chemotherapy or Calcium)
  o Type of electroporation
  o Patient satisfaction with the treatment
  o Regulatory information about the devices used
  - Follow-Up
  o Clinical response to the treatment
  o Patientl feedback on the treatment

  An eCRF will be used (Trialkit (https://www.crucialdatasolutions.com)) to collect the data at the site by a member of the care team.

• Research programme

  The aim of this study registry is to investigate the short and long term effect of electroporation in combination with chemotherapy (electrochemotherapy) and the short and long term effect of electroporation in combination with calcium (Ca-electroporation) in the management of skin and gastrointestinal cancers.

• Research database title

  Electroporation for cancer treatment real world registry

• Establishment organisation

  Mirai Medical

• Establishment organisation address

  5 Howley Court

  Oranmore

  Ireland