CivaDerm(TM) Surface Therapy Pilot Study

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.

Completed

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma of the Skin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

CivaDerm Oncology PLLC

Morrisville, North Carolina, 27560, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CivaDerm

Device

radioactive bandage

Primary outcomes

skin toxicity events

Time frame: within 2 months of treatment

grade 3+ events

Secondary outcomes

dose delivered to target

Time frame: 1 week

calculated radiation dose

Sponsors and collaborators

Lead sponsor

CivaTech Oncology

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Jul 21, 2020
Registry last updated: Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed