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Trial record 5 of 9 for:    calcium electroporation

Calcium Electroporation in Patients With Cell Changes in the Esophagus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04605419
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : October 28, 2020
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Michael Patrick Achiam, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Barretts Esophagus With High Grade Dysplasia Procedure: Calcium electroporation Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with Barrett's esophagus high-grade dysplasia will get calcium electroporation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Calcium Electroporation in Patients With Barrett's Esophagus High-grade Dysplasia
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: Calcium electroporation
Calcium chloride
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




Primary Outcome Measures :
  1. Registration of treatment related side effects assessed by CTCAE V 5.0 [ Time Frame: 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)

  2. Registration of treatment related pain through a Visual Analogue Score (VAS) [ Time Frame: 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 :
  1. The rate of patient's that have gained from the treatment [ Time Frame: Day 0 to 6 weeks after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04605419


Contacts
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Contact: Michael Achiam, MD., Ph.D. +45 35 45 04 41 Michael.Patrick.Achiam.01@regionh.dk
Contact: Laser Bazancir, Med. student +45 60 63 20 48 laser.arif.bazancir@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Region Hovedstaden, Denmark, 2100
Contact: Michael Achiam, Md., Ph.D.    +45 35 45 04 41    Michael.Patrick.Achiam.01@regionh.dk   
Sponsors and Collaborators
Michael Patrick Achiam
Danish Cancer Society
Investigators
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Principal Investigator: Michael Achiam, MD., Ph.D. Rigshospitalet, Department of Surgical Gastroenterology
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Responsible Party: Michael Patrick Achiam, Consultant, MD, DMSci, Ph.D., FEBS-OG, Ass. Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04605419    
Other Study ID Numbers: BEHGD-10-2020
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs