Basal Cell CarcinomaEarly Phase 1NCT04480645
CivaDerm(TM) Surface Therapy Pilot Study
A Early Phase 1 study testing CivaDerm in people with Basal Cell Carcinoma and Squamous Cell Carcinoma of the Skin, run by CivaTech Oncology at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Squamous Cell Carcinoma of the Skin
- What is being tested?
- CivaDerm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 30 Jan 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Is unable or unwilling to comply with the protocol requirements
- Pregnant or breast feeding
- Metastases
Trial locations and contacts
1 site in 1 country.
United States1 site
CivaDerm Oncology PLLC
Morrisville, North Carolina, 27560
About this study
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.
- Being tested
- CivaDerm
- Keywords
- radiation, brachytherapy, skin cancer
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CivaDermDevice
radioactive bandage
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Radioactive bandage applied to surface of the body worn for approximately one week. Receives: Device: CivaDerm |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin toxicity events
grade 3+ events
Measured: within 2 months of treatment
Secondary outcomes (1)
dose delivered to target
calculated radiation dose
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 May 2024
- Primary completion1 Dec 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pilot study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- CivaTech Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480645
- Sponsor's protocol ID
- CT008
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2020
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CivaDerm(TM) Surface Therapy Pilot Study
- ClinicalTrials.gov ID
- NCT04480645
- Acronym / sponsor ID
- CT008
- Keywords
- radiation, brachytherapy, skin cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CivaTech OncologyIndustry (pharma, biotech, devices)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pilot study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: CivaDermRadioactive bandage applied to surface of the body worn for approximately one week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Is unable or unwilling to comply with the protocol requirements
- Pregnant or breast feeding
- Metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CivaDermradioactive bandage | Device | Treatment |
Primary outcome
skin toxicity events
Time frame: within 2 months of treatment
grade 3+ events
1 secondary outcome
dose delivered to target
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CivaDerm in people with Basal Cell Carcinoma and Squamous Cell Carcinoma of the Skin, run by CivaTech Oncology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin toxicity events (time frame: within 2 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.