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| Name | Class |
|---|---|
| Danish Cancer Society | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium electroporation | Experimental | Calcium chloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium electroporation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 0 to 6 weeks after treatment |
| 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. | Day 0 to 6 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of patient's that have gained from the treatment | Day 0 to 6 weeks after treatment |
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Inclusion Criteria:
Exclusion Criteria:
A medical doctor will always be responsible for final inclusion of the subject.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Achiam, MD., Ph.D. | Contact | +45 35 45 04 41 | Michael.Patrick.Achiam.01@regionh.dk | |
| Laser Bazancir, Med. student | Contact | +45 60 63 20 48 | laser.arif.bazancir@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Michael Achiam, MD., Ph.D. | Rigshospitalet, Department of Surgical Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | Capital Region | 2100 | Denmark |
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Patients with Barrett's esophagus high-grade dysplasia will get calcium electroporation
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