CivaDerm(TM) Surface Therapy Pilot Study

Early Phase 1RecruitingNCT04480645

CivaTech Oncology10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Basal Cell Carcinoma Squamous Cell Carcinoma of the Skin

Interventions

CivaDermDEVICE

radioactive bandage

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

CivaDerm Oncology PLLC

Morrisville, North Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

skin toxicity events

grade 3+ events

Time frame: within 2 months of treatment

Secondary Outcomes

dose delivered to target

calculated radiation dose

Time frame: 1 week

Central Contacts

Kristy Perez, PhD

CONTACT

9193145515 kperez@civatechoncology.com

Carra Castagnero

CONTACT

9193145515 clinical@civatechoncology.com

Data from ClinicalTrials.gov

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