Electroporation for Cancer Treatment Real World Registry (PIONEER)

January 27, 2025 updated by: Mirai Medical
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, E1 1FR
        • Recruiting
        • Royal London Hospital
        • Contact:
          • Greme Moir
        • Principal Investigator:
          • Greme Moir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Any patient who has been treated using Calcium Electroporation
  • Any patient who has been treated using Electrochemotherapy
  • Patients must be mentally capable of understanding the information given
  • Patients must give written informed consent.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (CTCAE)
Time Frame: 5 years

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Evaluation Criteria in Solid Tumours (RECIST)
Time Frame: 3 months, 12 months, 3 years, 5 years
A response evaluation will be conducted at standard of care follow up
3 months, 12 months, 3 years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mirai Medical

Investigators

  • Study Director: SEAN H Kinsella, Mirai Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2021

Primary Completion (Estimated)

December 24, 2026

Study Completion (Estimated)

June 24, 2036

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-21-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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