Calcium Electroporation for Basal Cell Carcinomas - Proof... | NCT05046262

Studies
Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study

NCT05046262

Sponsor

Bispebjerg Hospital

Status

Unknown status

Last Update Posted

Sep 16, 2021Actual

Enrollment

25Estimated

Phase

Phase 3

Conditions

Basal Cell Carcinoma

Interventions

Calcium chloride

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2020Actual

Primary Completion Date

Feb 22, 2022Estimated

Completion Date

Feb 22, 2022Estimated

First Submitted Date

Sep 8, 2021

First Submission Date that Met QC Criteria

Sep 8, 2021

First Posted Date

Sep 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2021

Last Update Posted Date

Sep 16, 2021Actual

Name	Class
Mirai Medical, Ireland	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Calcium chloride	Drug	Calcium electroporation		electroporation

Measure	Description	Time Frame
complete response		3 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, Bispebjerg Hospital	Recruiting	Copenhagen		2400	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	May 17, 2023
Reset	Jan 31, 2024

Submission Tracking

Estimated Results First Submitted Date

May 17, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 17, 2023			Jan 31, 2024

Condition Browse Module

MeSH Terms

ID	Term
D002280	Carcinoma, Basal Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002122	Calcium Chloride
D018274	Electroporation

Ancestor Terms

ID	Term
D017610	Calcium Compounds
D007287	Inorganic Chemicals
D002712	Chlorides
D006851	Hydrochloric Acid

Browse Leaves

Not provided

Browse Branches

Not provided