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Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study

Primary Purpose

Basal Cell Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Calcium chloride
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

Primary low risk basal cell carcinoma less than 3 cm in diameter

-

Exclusion Criteria:

Immunosuppression or organ transplant recipients Pregnancy or breastfeeding Allergy to local anesthetics

Sites / Locations

  • Department of Dermatology, Bispebjerg HospitalRecruiting

Outcomes

Primary Outcome Measures

complete response

Secondary Outcome Measures

Full Information

First Posted
September 8, 2021
Last Updated
September 8, 2021
Sponsor
Bispebjerg Hospital
Collaborators
Mirai Medical, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT05046262
Brief Title
Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study
Official Title
Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
February 22, 2022 (Anticipated)
Study Completion Date
February 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
Mirai Medical, Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation
Detailed Description
25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation, if partial or no response after 3 months the treatment was repeated. Follow-up 3 and 12 months after last treatment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Calcium chloride
Other Intervention Name(s)
electroporation
Intervention Description
Calcium electroporation
Primary Outcome Measure Information:
Title
complete response
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary low risk basal cell carcinoma less than 3 cm in diameter - Exclusion Criteria: Immunosuppression or organ transplant recipients Pregnancy or breastfeeding Allergy to local anesthetics
Facility Information:
Facility Name
Department of Dermatology, Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stine Wiegell, MD PhD
Phone
+4530914617
Email
stine.regin.wiegell@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study

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