Calcium Electroporation in Patients With Cell Changes in the Esophagus

NCT04605419 | Unknown Phase 1 DMC

• 1 other identifier: BEHGD-10-2020
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Barretts Esophagus With High Grade Dysplasia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

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

  Day 0 to 6 weeks after treatment

Study Arms (1)

Calcium electroporation

EXPERIMENTAL

Calcium chloride

Procedure: Calcium electroporation

Interventions

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

Calcium electroporation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Patrick Achiam: lead
• Danish Cancer Society: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Study Officials

• Michael Achiam, MD., Ph.D.

  Rigshospitalet, Department of Surgical Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant, MD, DMSci, Ph.D., FEBS-OG, Ass. Professor

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

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 28, 2020
• Study Start: October 7, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

DK (1)