CivaDerm(TM) Surface Therapy Pilot Study

CivaTech Oncology

Status and phase: Enrolling; Early Phase 1

Conditions: Squamous Cell Carcinoma of the Skin; Basal Cell Carcinoma

Treatments: Device: CivaDerm

Study type: Interventional

Funder types: Industry

Identifiers

NCT04480645

CT008

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment

Experimental group

Description:

Radioactive bandage applied to surface of the body worn for approximately one week.

Treatment:

Device: CivaDerm