Barretts Esophagus With High Grade DysplasiaPhase 1NCT04605419
Calcium Electroporation in Patients With Cell Changes in the Esophagus
A Phase 1 study testing Calcium electroporation in people with Barretts Esophagus With High Grade Dysplasia, run by Michael Patrick Achiam at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barretts Esophagus With High Grade Dysplasia
- What is being tested?
- Calcium electroporation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Oct 2020to 1 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Capital Region, 2100
Michael Achiam, Md., Ph.D., +45 35 45 04 41, Michael.Patrick.Achiam.01@regionh.dk
About this study
Official title: Calcium Electroporation in Patients With Barrett's Esophagus High-grade Dysplasia
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.
Read the 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.
- Being tested
- Calcium electroporation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium electroporationProcedure or surgery
Areas with Barrett's esophagus high-grade dysplasia will get an injection of calcium chloride in submucosa through an endoscopic system before getting electroporation
| Study group | Role | What they receive |
|---|---|---|
| Calcium electroporation | Experimental | Calcium chloride Receives: Procedure: Calcium electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Day 0 to 6 weeks after treatment
Secondary outcomes (1)
The rate of patient's that have gained from the treatment
Measured: Day 0 to 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start7 Oct 2020
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barretts Esophagus With High Grade DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with Barrett's esophagus high-grade dysplasia will get calcium electroporation
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Patrick Achiam
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Sponsor-investigator, Michael Patrick Achiam, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Michael Achiam, MD., Ph.D., Principal investigator, Rigshospitalet, Department of Surgical Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605419
- Sponsor's protocol ID
- BEHGD-10-2020
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Electroporation in Patients With Barrett's Esophagus High-grade Dysplasia
- ClinicalTrials.gov ID
- NCT04605419
- Acronym / sponsor ID
- BEHGD-10-2020
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Michael Patrick AchiamUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with Barrett's esophagus high-grade dysplasia will get calcium electroporation
| Arm | Type | Receives |
|---|---|---|
| Calcium electroporation | Experimental | Procedure: Calcium electroporationCalcium chloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium electroporationAreas with Barrett's esophagus high-grade dysplasia will get an injection of calcium chloride in submucosa through an endoscopic system before getting electroporation | Procedure or surgery | Calcium electroporation |
Primary outcome
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)
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.
1 secondary outcome
The rate of patient's that have gained from the treatment
Time frame: Day 0 to 6 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Achiam, MD., Ph.D. principal investigator
Rigshospitalet, Department of Surgical Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calcium electroporation in people with Barretts Esophagus With High Grade Dysplasia, run by Michael Patrick Achiam at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Achiam, MD., Ph.D. (+45 35 45 04 41, Michael.Patrick.Achiam.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registration of treatment related side effects assessed by CTCAE V 5.0 (time frame: Day 0 to 6 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.