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NCT04480645 Clinical Trial

CivaDerm(TM) Surface Therapy Pilot Study

Basal Cell Carcinoma Clinical Trial

Official title:
CivaDerm(TM) Surface Therapy Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04480645
Other study ID # CT008
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date October 1, 2022
Est. completion date April 30, 2023

Study information
Verified date July 2022
Source CivaTech Oncology
Contact Kristy Perez, PhD
Phone 9193145515
Email kperez@civatechoncology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date April 30, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• CivaDerm
radioactive bandage

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
CivaTech Oncology

Outcome
Type Measure Description Time frame Safety issue
Primary skin toxicity events grade 3+ events within 2 months of treatment
Secondary dose delivered to target calculated radiation dose 1 week
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