Spots Global Cancer Trial Database for Calcium Electroporation in Patients With Cell Changes in the Esophagus

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Trial Identification

Brief Title: Calcium Electroporation in Patients With Cell Changes in the Esophagus

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

Study ID: NCT04605419

Conditions

Barretts Esophagus With High Grade Dysplasia

Interventions

Calcium electroporation

Study Description

Brief Summary: 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: 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.