NCT04605419

Calcium Electroporation in Patients With Cell Changes in the Esophagus

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Michael Patrick Achiam · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Barretts Esophagus With High Grade Dysplasia

Interventions

Type	Name	Description
PROCEDURE	Calcium electroporation	Areas with Barrett's esophagus high-grade dysplasia will get an injection of calcium chloride in submucosa through an endoscopic system before getting electroporation

Timeline

• Start date: 2020-10-07
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2020-10-28
• Last updated: 2020-10-28

Locations

1 site across 1 country: Denmark