Calcium Electroporation in Patients With Cell Changes in the Esophagus

Study Overview
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Brief Summary
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The aim of this first-in-man study is to evaluate the safety of calcium electroporation used in patients with Barrett's esophagus high-grade dysplasia through an endoscopic system.

Detailed Description
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After being informed about the study and potential risks, all patients give written informed consent. Thereafter, patient will get calcium electroporation with biopsies and digital photographs on day 0. We expect to discharge all patients same evening. Between day 3-7 an examination is followed by gastroscopy with biopsies and digital photographs. On day 14 the patients are followed in our outpatient clinic. 6 weeks after treatment the patients will undergo endoscopic mucosa resection (EMR) or endoscopic submucosa dissection (ESD) surgery and thereby the standard care of treatment for Barrett's esophagus high-grade dysplasia.

Official Title
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Calcium Electroporation in Patients With Barrett's Esophagus High-grade Dysplasia

Conditions
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Barretts Esophagus With High Grade Dysplasia

Intervention / Treatment
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* Procedure: Calcium electroporation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥18 years old. Histological verified Barrett's esophagus high-grade dysplasia (BE HGD) Expected survival > 3 months. Performance status Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) ≤ 2. Platelets ≥ 50 billion/l, International Normalized Ratio (INR) < 1.5. Medical correction is allowed, e.g. correction of a high International Normalized Ratio (INR) using vitamin K. Subjects must be willing and able to comply with the procedure, such as agreed follow-up visits. Sexually active men and fertile women must use adequate contraception during this trial Subjects must give written informed consent. Exclusion Criteria: Coagulation disorder that cannot be corrected. Subjects with a clinically significant cardiac arrhythmia. Concurrent treatment with an investigational medicinal product Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements. Pregnancy or lactation A medical doctor will always be responsible for final inclusion of the subject.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with Barrett's esophagus high-grade dysplasia will get calcium electroporation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium electroporation<br>Calcium chloride | Procedure: Calcium electroporation<br>* Areas with Barrett's esophagus high-grade dysplasia will get an injection of calcium chloride in submucosa through an endoscopic system before getting electroporation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Registration of treatment related side effects assessed by CTCAE V 5.0 | This is part of a safety evaluation and will be registered by CTCAE into Adverse Events (AE) and Serious Adverse Events (SAE) | Day 0 to 6 weeks after treatment | 
| Registration of treatment related pain through a Visual Analogue Score (VAS) | Second part of safety evaluation which will be registered by VAS score. The VAS score is a scale with values from 0-10, where 0 is no pain and 10 is the worst possible pain. | Day 0 to 6 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of patient's that have gained from the treatment |  | Day 0 to 6 weeks after treatment |