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Calcium Electroporation in Patients With Cell Changes in the Esophagus

Primary Purpose

Barretts Esophagus With High Grade Dysplasia

Status

Unknown status

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

Calcium electroporation

About this trial

This is an interventional treatment trial for Barretts Esophagus With High Grade Dysplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Sites / Locations

RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Calcium electroporation

Arm Description

Calcium chloride

Outcomes

Primary Outcome Measures

Registration of treatment related side effects assessed by CTCAE V 5.0

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)

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

The rate of patient's that have gained from the treatment

Full Information

NCT ID

NCT04605419

First Posted

October 20, 2020

Last Updated

October 27, 2020

Sponsor

Michael Patrick Achiam

Collaborators

Danish Cancer Society

1. Study Identification

Unique Protocol Identification Number

NCT04605419

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 Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 7, 2020 (Actual)

Primary Completion Date

September 1, 2021 (Anticipated)

Study Completion Date

September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michael Patrick Achiam

Collaborators

Danish Cancer Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Barretts Esophagus With High Grade Dysplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Calcium electroporation

Arm Type

Experimental

Arm Description

Calcium chloride

Intervention Type

Procedure

Intervention Name(s)

Calcium electroporation

Intervention Description

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

Primary Outcome Measure Information:

Title

Registration of treatment related side effects assessed by CTCAE V 5.0

Description

This is part of a safety evaluation and will be registered by CTCAE into Adverse Events (AE) and Serious Adverse Events (SAE)

Time Frame

Day 0 to 6 weeks after treatment

Title

Registration of treatment related pain through a Visual Analogue Score (VAS)

Description

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.

Time Frame

Day 0 to 6 weeks after treatment

Secondary Outcome Measure Information:

Title

The rate of patient's that have gained from the treatment

Time Frame

Day 0 to 6 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female ≥18 years old. Histological verified Barrett's esophagus high-grade dysplasia (BE HGD) Expected survival > 3 months. Performance status Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) ≤ 2. 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. Subjects must be willing and able to comply with the procedure, such as agreed follow-up visits. Sexually active men and fertile women must use adequate contraception during this trial Subjects must give written informed consent. Exclusion Criteria: Coagulation disorder that cannot be corrected. Subjects with a clinically significant cardiac arrhythmia. Concurrent treatment with an investigational medicinal product 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. Pregnancy or lactation A medical doctor will always be responsible for final inclusion of the subject.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Achiam, MD., Ph.D.

Phone

+45 35 45 04 41

Michael.Patrick.Achiam.01@regionh.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Laser Bazancir, Med. student

Phone

+45 60 63 20 48

laser.arif.bazancir@regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Achiam, MD., Ph.D.

Organizational Affiliation

Rigshospitalet, Department of Surgical Gastroenterology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

State/Province

Region Hovedstaden

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Achiam, Md., Ph.D.

Phone

+45 35 45 04 41

Michael.Patrick.Achiam.01@regionh.dk

12. IPD Sharing Statement

Learn more about this trial

Calcium Electroporation in Patients With Cell Changes in the Esophagus

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