Clinical trial · Observational
Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo.
Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo
NCT00601185CI-TRIAL-00031825completedClinicalTrials.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)
The purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. The goal is to develop a technique that may enable fast and accurate detection of skin disorders and cancers for future clinical diagnosis and surgical use.
Conditions
Conditions (4)
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 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-Malignant Skin Disorders | — | UNRESOLVED | — |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| confocal microscopy in vivo | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Patients undergoing a shave biopsy and confocal microscopy.
- interventionNames
- Procedure: confocal microscopy in vivo
Primary outcomes (1)
- measure
- is to evaluate and quantify the technical feasibility of reflectance CSLM imaging of shave-biopsy sites on skin in vivo.
- timeFrame
- conclusion of study
Secondary outcomes (1)
- measure
- To assess the quality of the CSLM images of the biopsy sites to determine a point estimate of the proportion of images that will be of acceptable quality for formal analysis in the planned study of intraoperative margin detection.
- timeFrame
- conclusion of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing shave-biopsy on an anatomical site that is readily accessible to the VivaScope 1500 (for example, chest, back, legs, arms, cheek, forehead). * The additional 110 patients for this amendment will be imaged with the newly developed Vivascope 3000 handheld confocal microscope. * Ability to sign informed consent. * Age ≥ 18 years. Exclusion Criteria: * Shave-biopsy located on a site that is not amenable to confocal imaging (for example, adjacent to the nose, ears or eyes, fingers, toes). * Inability to give informed consent. * Known hypersensitivity to adhesive rings. * Inability to tolerate imaging procedure (i. e., remain relatively still for multiple short durations of 3-4 minutes).
References
Publications (0)
Data not yet available
No reference posted for this study.