CivaDerm(TM) Surface Therapy Pilot Study

NCT04480645 — Early Phase 1, Completed, 10 participants, CivaTech Oncology

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Registry	NCT04480645
Status	Completed
Phase	Early Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	10 (Actual)
Sponsor	CivaTech Oncology (Industry)
Conditions	Basal Cell Carcinoma, Squamous Cell Carcinoma of the Skin
Interventions	CivaDerm (Device)
Dates	start 2024-05-01, primary completion 2025-12-01, completion 2026-01-30, first posted 2020-07-21, last updated 2026-03-24
Locations	1 site in United States

-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.

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+Arms and interventions

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

CivaDerm (Device): radioactive bandage

+Outcome measures

Primary outcomes

skin toxicity events [within 2 months of treatment]: grade 3+ events

Secondary outcomes

dose delivered to target [1 week]: calculated radiation dose

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
CivaDerm Oncology PLLC	Morrisville, North Carolina	United States