CivaDerm(TM) Surface Therapy Pilot Study | NCT04480645

Studies
CivaDerm(TM) Surface Therapy Pilot Study

NCT04480645

Sponsor

CivaTech Oncology

Status

Completed

Last Update Posted

Mar 24, 2026Actual

Enrollment

10Actual

Phase

Early Phase 1

Conditions

Basal Cell Carcinoma
Squamous Cell Carcinoma of the Skin

Interventions

CivaDerm

Countries

United States

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2024Actual

Primary Completion Date

Dec 1, 2025Actual

Completion Date

Jan 30, 2026Actual

First Submitted Date

Jul 16, 2020

First Submission Date that Met QC Criteria

Jul 20, 2020

First Posted Date

Jul 21, 2020Actual

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

Mar 20, 2026

Last Update Posted Date

Mar 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a pilot study to determine the usefulness of new brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit basal cell and squamous cell carcinoma patients by providing conformal radiation therapy to the surface of the skin.

Detailed Description

Not provided

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Radioactive bandage applied to surface of the body worn for approximately one week.	Device: CivaDerm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CivaDerm	Device	radioactive bandage	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
skin toxicity events	grade 3+ events	within 2 months of treatment

Secondary Outcomes

Measure	Description	Time Frame
dose delivered to target	calculated radiation dose	1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subject signed informed consent
Confirmed superficial or nodular basal cell or squamous cell carcinoma
Biopsy proven on chest, stomach, back, arms, legs, feet (trunk and extremities)
>5 mm of residual tumor
tumors < 3 cm
Capable of complying with Patient Release Instructions

Exclusion Criteria:

Is unable or unwilling to comply with the protocol requirements
Pregnant or breast feeding
Metastases

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
CivaDerm Oncology PLLC		Morrisville	North Carolina	27560	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002280	Carcinoma, Basal Cell
D012878	Skin Neoplasms

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