Skin CancerPIONEERNCT04929912
Electroporation for Cancer Treatment Real World Registry
An observational study of Skin Cancer and Gastrointestinal Cancer, run by Mirai Medical at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Cancer, Gastrointestinal Cancer
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jun 2021to 24 Jun 2036
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Declan Soden contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal London Hospital
London, E1 1FR
Greme Moir
Greme Moir
About this study
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
- Medical subject headings
- Skin Neoplasms, Gastrointestinal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 years
Secondary outcomes (1)
Response Evaluation Criteria in Solid Tumours (RECIST)
A response evaluation will be conducted at standard of care follow up
Measured: 3 months, 12 months, 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start24 Jun 2021
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Mirai Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SEAN H Kinsella, Study director, Mirai Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929912
- Sponsor's protocol ID
- CIP-21-001
- Acronym
- PIONEER
- Status last verified
- Jan 2025
- First submitted
- 10 Jun 2021
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroporation for Cancer Treatment Real World Registry
- ClinicalTrials.gov ID
- NCT04929912
- Acronym / sponsor ID
- PIONEER / CIP-21-001
- Conditions
- Skin Cancer, Gastrointestinal Cancer
- Keywords
- Pulsed Electric Fields, Reversible Electroporation, Electrochemotherapy, Ca-Electroporation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Mirai MedicalIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 24 Jun 2036 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Response Evaluation Criteria in Solid Tumours (RECIST)
Time frame: 3 months, 12 months, 3 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Declan Soden contact
SEAN H Kinsella study director
Mirai Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer and Gastrointestinal Cancer, run by Mirai Medical at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEAN H KINSELLA (+353 91 442 498, sean@mirai-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (CTCAE) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.