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Clinical Trials/NCT04480645
NCT04480645
Completed
Early Phase 1

CivaDerm(TM) Surface Therapy Pilot Study

CivaTech Oncology1 site in 1 country10 target enrollmentMay 1, 2024
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ConditionsBasal Cell CarcinomaSquamous Cell Carcinoma of the Skin

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Basal Cell Carcinoma
Sponsor
CivaTech Oncology
Enrollment
10
Locations
1
Primary Endpoint
skin toxicity events
Status
Completed
Last Updated
last month
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
January 30, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
CivaTech Oncology
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

skin toxicity events

Time Frame: within 2 months of treatment

grade 3+ events

Secondary Outcomes

  • dose delivered to target(1 week)

Study Sites (1)

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