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CompletedNCT04480645Updated Mar 24, 2026

CivaDerm(TM) Surface Therapy Pilot Study

An Early Phase 1 interventional study of CivaDerm in Basal Cell Carcinoma and Squamous Cell Carcinoma of the Skin, sponsored by CivaTech Oncology. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by CivaTech Oncology · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Basal Cell Carcinoma
  • Squamous Cell Carcinoma of the Skin

Keywords

  • radiation
  • brachytherapy
  • skin cancer
03

In context

Carcinoma, Basal Cell

364 studies on the registry are indexed under Carcinoma, Basal Cell; 66 are open to participants now.

This study's enrollment of 10 is below the median of 41 across 258 interventional studies indexed under Carcinoma, Basal Cell.

Browse Carcinoma, Basal Cell studies →

Lead sponsor

CivaTech Oncology is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Is unable or unwilling to comply with the protocol requirements
  • Pregnant or breast feeding
  • Metastases
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Treatment

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

    Device: CivaDerm

Interventions

  • DeviceCivaDerm

    radioactive bandage

06

What researchers measure

Primary outcomes

  1. skin toxicity events

    grade 3+ events

    Time frame: within 2 months of treatment

Secondary outcomes

  1. dose delivered to target

    calculated radiation dose

    Time frame: 1 week

07

Study locations

1 site
  • CivaDerm Oncology PLLC
    Morrisville, North Carolina 27560, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04480645
Lead sponsor
CivaTech Oncology
Responsible party
Sponsor
First posted
Jul 21, 2020
Start date
May 1, 2024
Primary completion
Dec 1, 2025
Completion
Jan 30, 2026
Last update
Mar 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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