Calcium Electroporation in Patients With Cell Changes in the Esophagus

Phase 1

• Conditions: Barretts Esophagus With High Grade Dysplasia
• Interventions: Procedure: Calcium electroporation

• Registration Number: NCT04605419
• Lead Sponsor: Michael Patrick Achiam

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.

Study Timeline

• Status Verified: 2020-10
• Study Start: 2020-10-07
• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Study First Posted: 2020-10-28
• Last Update Posted: 2020-10-28
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Male or female ≥18 years old.
2. Histological verified Barrett's esophagus high-grade dysplasia (BE HGD)
3. Expected survival > 3 months.
4. Performance status Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) ≤ 2.
5. 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.
6. Subjects must be willing and able to comply with the procedure, such as agreed follow-up visits.
7. Sexually active men and fertile women must use adequate contraception during this trial
8. Subjects must give written informed consent.

Exclusion Criteria

1. Coagulation disorder that cannot be corrected.
2. Subjects with a clinically significant cardiac arrhythmia.
3. Concurrent treatment with an investigational medicinal product
4. 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.
5. Pregnancy or lactation

A medical doctor will always be responsible for final inclusion of the subject.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Calcium electroporation	Calcium electroporation	Calcium chloride

Primary Outcome Measures

Name	Time	Method
Registration of treatment related side effects assessed by CTCAE V 5.0	Day 0 to 6 weeks after treatment	This is part of a safety evaluation and will be registered by CTCAE into Adverse Events (AE) and Serious Adverse Events (SAE)
Registration of treatment related pain through a Visual Analogue Score (VAS)	Day 0 to 6 weeks after treatment	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.

Secondary Outcome Measures

Name	Time	Method
The rate of patient's that have gained from the treatment	Day 0 to 6 weeks after treatment

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Region Hovedstaden, Denmark