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Devices and Electrode Technology

In electroporation-based therapy the drug is not the only determinant of outcome: the electric field distribution in the tissue matters just as much. That distribution is set jointly by electrode geometry, inter-electrode distance, applied voltage and the tissue’s own conductivity. The extended electroporation corpus holds 37 technical/device studies and 148 modelling studies.

Clinical Reference. This section is independent of the portal's publication counting: the values here are not computed from the corpus but taken from the named procedure, guidance and manufacturer documents, each shown with its source. When the source document is revised, this page changes with it. If you spot an error on this page, write to info@dgmed.com.tr. The portal publishes no clinical review record (reviewer and date) for this page; the content is transcribed from the source documents named above, and what binds are the current versions of those documents.

Examples of Electroporation Systems Represented in the Literature Corpus

SystemManufacturerRegime and contextMentions in corpus
CliniporatorIGEA (Italy)Electrochemotherapy; cutaneous and subcutaneous tumour nodules762 records name it (VITAE included) · 312 human clinical · 296 records with evidenced use
Cliniporator VITAEIGEA (Italy)Electrochemotherapy; deep-seated tumours90 records name it · 52 human clinical · 79 records with evidenced use
NanoKnifeAngioDynamics (USA)Irreversible electroporation; non-thermal ablation561 records name it · 257 human clinical · 318 records with evidenced use
SENNEXBIONMED Technologies (Germany)Electrochemotherapy; cutaneous and subcutaneous tumours19 records name it · 6 human clinical · 10 records with evidenced use
AliyaGalvanize Therapeutics (USA)Pulsed electric field; soft tissue ablation14 records name it · 2 human clinical · 5 records with evidenced use

This table is not a market survey and the counts are not an indicator of market share, effectiveness or superiority; they say only how many records of the corpus carry the name. Approval and licensing status in your country is not assessed here; consult the manufacturer’s current instructions for use and the record of your competent authority.

Cliniporator

The system on which the ESOPE procedures were defined; works with type I–III electrodes. The 2006 procedure states that the device stores the electrical parameters used for treatment, including traces of the voltage applied and the current delivered during treatment. A review enumerating the certified clinical electroporators lists the system for electrochemotherapy and gene electrotransfer.

Cliniporator VITAE

The manufacturer’s technical sheet describes variable-geometry needle electrodes with selectable active tip and total length, in 12–24 cm lengths, and states that the device measures and displays voltage and current waveforms during the procedure. Placing such electrodes in the liver according to a treatment plan is described separately. A review states that the version received a CE mark in 2011 and extended electrochemotherapy to deep-seated and larger tumours.

NanoKnife

In one published application, needle electrodes were placed into the lesion under ultrasound guidance, the voltage was set to 2,400–2,700 V, and the pulses were delivered in the absolute refractory period using electrocardiographic synchronisation. The review enumerating the certified clinical electroporators lists the system as one that may be used for soft-tissue ablation.

SENNEX

In one published case, eight square-wave pulses per application were delivered with a six-needle applicator, at a pulse duration of 0.1 ms and a field strength of 1,100 V/cm. An animal study describes two parallel needle electrodes 8 mm apart and a pulse duration of 100 µs with the same system. The review enumerating the certified clinical electroporators lists the system as one used for electrochemotherapy only, and a further review states that it is CE-marked for electrochemotherapy of cutaneous and subcutaneous tumours. , Manufacturer information for SENNEX →

Aliya

A dose-response study in an orthotopic murine model measures how ablation volume and thermal load vary with the dose delivered. A review reports that the system received US clearance for soft tissue ablation in 2022. A prospective study reporting six-month local control rates was also conducted with this system.

Which systems enter the table?

A platform enters this table because its name occurs in the full text of at least 10 records of the extended electroporation corpus and the archive holds a manufacturer document for it. A platform below that threshold still enters if the archive holds a manufacturer document and at least one human clinical publication names it as the system used for treatment, so that a system with few mentions but direct clinical evidence is not excluded on mention count alone. All five platforms currently listed meet the first condition.

The count is taken from the record’s full text. A publication usually states the device it used in the Methods section; a count limited to title and abstract under-reported every platform. The second figure shows how many of those records are clinical designs conducted in humans; reviews and animal studies are not counted there. Where a publication used more than one system, its aggregate outcomes are not attributed to a single system. Versions of the same platform are shown as separate rows.

ePORE occurs in 35 records of the corpus but is not listed, because the archive holds no manufacturer document for it.

Why Is Field Distribution Critical?

Electroporation is threshold-based: for a cell’s membrane to become permeable, the field strength at its own location must exceed the threshold. That threshold is not a single sharp line and varies with tissue conductivity, cell type, pulse amplitude and duration; where the field is insufficient, the electroporation-enhanced uptake is not expected to reach its target level and that volume counts as incompletely covered.

The practical goal is therefore to cover the whole tumour and its margin with a supra-threshold field. In thick or irregular lesions this is achieved by overlapping electrode applications.

Tissue conductivity is not homogeneous: fat, muscle, tumour and bone differ, and the field bends at those boundaries. For deep-seated tumours this brings patient-specific treatment planning into play: the field distribution is computed by finite-element methods on a tissue model derived from imaging, and electrode positions follow from it. ,

Most of the modelling studies in the corpus address exactly this problem, the calculation that runs from electrode placement to field distribution.

Monitoring Features Reported for Selected Systems

Each feature, with the system and the publication it is reported in

Current measurement

Reported for: Cliniporator , Cliniporator VITAE , NanoKnife

The 2006 ESOPE procedure states that the Cliniporator delivering the pulses stores the electrical parameters used for treatment, together with traces of the voltage applied and the current delivered. The manufacturer’s technical sheet states that the Cliniporator VITAE measures and displays voltage and current waveforms during the procedure. On the IRE side, a 2014 study reports that currents measured with an external current probe setup deviated on average by 0.371% from the final outputs of the NanoKnife generator, and writes that real-time current monitoring was at that time not available in clinical IRE generators.

The same study writes that the current should be kept in a range that is sufficient for a clinically relevant ablation without exceeding safe limits. In an ECT series of 131 patients with head and neck tumours the current flowing through the tissue during treatment was recorded; the median current was reported as 6.6 A in patients with a partial response and 3.3 A in those without one.

Voltage verification

Reported for: Cliniporator , Cliniporator VITAE , NanoKnife

The ESOPE study report derives the amplitude of the pulses delivered with the Cliniporator from an amplitude-to-distance ratio of 1,000–1,300 V/cm, depending on electrode type. The manufacturer’s technical sheet states that the Cliniporator VITAE measures and displays the voltage waveform during the procedure. In one published case using NanoKnife electrodes the electrodes were placed 1.4 cm apart and the voltage was set to 2,400–2,700 V.

The amplitude-to-distance ratio (V/cm) is obtained by dividing the applied voltage by the inter-electrode distance; within the ESOPE framework the voltage is chosen from that ratio and the electrode type. , In one modelling study the voltage and current limits of the pulse generator acted as constraints while pulse amplitude and electrode distance were optimised, and prevented the whole tumour volume from being exposed to a supra-threshold field.

Impedance monitoring

Reported for: This portal’s search of the corpus found no record tying the measurement to a named clinical system; the measurement is reported in research setups and experimental models

In ex vivo soft-tissue sarcoma samples the resistance was computed from the voltage and current recorded by the equipment in a fixed measurement setup. A 2021 technical study developed a rapid impedance spectroscopy method for monitoring impedance in real time during electroporation-based therapies and validated it in potato tissue; it finds the spectrum acquisition time of commercial instruments too long for this purpose. On the IRE side, a 2015 study describes the absence of methods for real-time treatment evaluation as a clinical limitation and proposes an impedance-sensing probe.

In a cell suspension, increased membrane permeability is accompanied by increased conductivity; measuring conductivity during the pulses can show that the permeabilisation threshold has been passed, but does not give the level of permeabilisation directly. In measurements in mouse liver, physiological effects such as the vascular lock are reported as possibly dominating the impedance change.

ECG synchronisation

Reported for: Cliniporator , NanoKnife

A 2017 chapter on the development of the Cliniporator writes that operating during open surgery required the device to be able to stay synchronised with the absolute refractory period of the heart. In one case using NanoKnife electrodes the pulses were delivered in the absolute refractory period with electrocardiographic synchronisation. A separate research group evaluated the performance of its own synchronisation algorithm on electrocardiogram recordings from patients; that report is for the group’s own algorithm, not for a feature of a commercial system.

For tissues close to the heart, synchronising the pulses with the electrocardiogram is described as the method by which safety is ensured ; for IRE near the heart, ventricular arrhythmias are reported to be preventable with this synchronisation . In one case report the synchronisation device failed to operate properly and pulses were delivered in the relative rather than the absolute refractory period; the authors write that this risk stays small but real even when a synchronisation device is used.

This section relays only published literature; the portal makes no claim of its own about any system’s intended purpose, safety or performance. A feature reported in one publication does not generalise to every version of the platform or to an approved intended purpose, and its absence from a publication does not mean the feature is absent. The binding document is the manufacturer’s instructions for use and labelling.