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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04605419
Study type Interventional
Source Rigshospitalet, Denmark
Contact Michael Achiam, MD., Ph.D.
Phone +45 35 45 04 41
Email Michael.Patrick.Achiam.01@regionh.dk
Status Recruiting
Phase Phase 1
Start date October 7, 2020
Completion date September 1, 2021

See also
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