Electroporation for Cancer Treatment Real World Registry

NCT04929912 | Recruiting DMC

• 1 other identifier: CIP-21-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Cancer; Gastrointestinal Cancer

Keywords

Pulsed Electric Fields; Reversible Electroporation; Electrochemotherapy; Ca-Electroporation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Response Evaluation Criteria in Solid Tumours (RECIST)

  3 months, 12 months, 3 years, 5 years

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Mirai Medical: lead

Study Sites (1)

Royal London Hospital

London, E1 1FR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• SEAN H Kinsella

  Mirai Medical

  STUDY DIRECTOR

Central Study Contacts

SEAN H KINSELLA

CONTACT

+353 91 442 498; sean@mirai-medical.com

Declan Soden

CONTACT

declan@mirai-medical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 18, 2021
• Study Start: June 24, 2021
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): June 24, 2036
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)