Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study

NCT ID: NCT05046262

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-08

Study Completion Date

2022-02-22

Brief Summary

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25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation

Detailed Description

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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.

Conditions

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Basal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Calcium chloride

Calcium electroporation

Intervention Type DRUG

Other Intervention Names

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electroporation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mirai Medical, Ireland

UNKNOWN

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stine Wiegell

MD, PhD, DMSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Dermatology, Bispebjerg Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Stine Wiegell, MD PhD

Role: primary

+4530914617

Other Identifiers

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EudraCT 2019-002730-36

Identifier Type: -

Identifier Source: org_study_id

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