Clinical trial · Interventional
CivaDerm(TM) Surface Therapy Pilot Study
NCT04480645CI-TRIAL-00106284completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Squamous Cell Carcinoma of the Skin | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CivaDerm | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Radioactive bandage applied to surface of the body worn for approximately one week.
- interventionNames
- Device: CivaDerm
Primary outcomes (1)
- measure
- skin toxicity events
- timeFrame
- within 2 months of treatment
- description
- grade 3+ events
Secondary outcomes (1)
- measure
- dose delivered to target
- timeFrame
- 1 week
- description
- calculated radiation dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.