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ElectroPoration In a Clinical Setting

NCT04698694 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-04-21

No results posted yet for this study

Summary

This is a single-blind, single-center, randomized, study in healthy subjects in which the volunteer patients will remain blind with respect to the voltage strength received.

Conditions

  • Tolerance

Interventions

DEVICE

Electroporation with voltage amplitude of 40 V (corresponding to an electric field strength of 100 V/cm)

The physician will select the voltage amplitude of 40 V to be given to the subject based on a randomization list, while the subject will remain blind to the voltage he/she is assigned to. The electroporation will be performed with a EPS electrode gun.

DEVICE

Electroporation with voltage amplitude of 60 V (corresponding to an electric field strength of 150 V/cm)

The physician will select the voltage amplitude of 60 V to be given to the subject based on a randomization list, while the subject will remain blind to the voltage he/she is assigned to. The electroporation will be performed with a EPS electrode gun.

Sponsors & Collaborators

  • Rottapharm

    collaborator INDUSTRY

  • University of Milano Bicocca

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2020-12-14
Completion
2020-12-21

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04698694 on ClinicalTrials.gov