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Calcium Electroporation in Patients With Cell Changes in the Esophagus

NCT ID: NCT04605419

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-07

Study Completion Date

2021-09-01

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.

Conditions

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Barretts Esophagus With High Grade Dysplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients with Barrett's esophagus high-grade dysplasia will get calcium electroporation
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Calcium electroporation

Calcium chloride

Group Type EXPERIMENTAL

Calcium electroporation

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

Michael Patrick Achiam

OTHER

Sponsor Role lead

Responsible Party

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Michael Patrick Achiam

Consultant, MD, DMSci, Ph.D., FEBS-OG, Ass. Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael Achiam, MD., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Department of Surgical Gastroenterology

Locations

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Rigshospitalet

Copenhagen, Capital Region, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Michael Achiam, MD., Ph.D.

Role: CONTACT

[email protected]
+45 35 45 04 41

Laser Bazancir, Med. student

Role: CONTACT

[email protected]
+45 60 63 20 48

Facility Contacts

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Michael Achiam, Md., Ph.D.

Role: primary

[email protected]
+45 35 45 04 41

Other Identifiers

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BEHGD-10-2020

Identifier Type: -

Identifier Source: org_study_id