CivaDerm(TM) Surface Therapy Pilot Study

Early Phase 1

Recruiting

• Conditions: Squamous Cell Carcinoma of the Skin; Basal Cell Carcinoma
• Interventions: Device: CivaDerm

• Registration Number: NCT04480645
• Lead Sponsor: CivaTech Oncology

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 available

Study Timeline

• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-21
• Study Start: 2024-05-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-12-01
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	CivaDerm	Radioactive bandage applied to surface of the body worn for approximately one week.

Primary Outcome Measures

Name	Time	Method
skin toxicity events	within 2 months of treatment	grade 3+ events

Secondary Outcome Measures

Name	Time	Method
dose delivered to target	1 week	calculated radiation dose

Trial Locations

Locations (1)

CivaDerm Oncology PLLC; 🇺🇸 Morrisville, North Carolina, United States