Safety Validation of EndoSWIR Device
- Conditions
- Optical Guided Surgery
- Interventions
- Device: EndoSWIR
- Registration Number
- NCT04274309
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
Head and neck cancer has an incidence of 600,000 cases per year worldwide (6th among cancers) and cause 380,000 death per year. Surgical resection is guided by the surgeon's inspection and palpation of the tumor. The prognosis of patients depends on the quality of the lesion's resection. The ENDOSWIR dispositive developed by engineers of Atomic Energy Comity of Grenoble allows for reliable and accurate analysis of tumor margins.
The camera provides a spectral analysis of the tissues according to their composition. We want to show that the prognosis of patients is improved by the use of this device. For that we need to prove first that it is not toxic for tissue analysis.
- Detailed Description
ENDOSWIR dispositive is a InGaAs (Indium Gallium Arsenide) camera working at ambient temperature. The light is a quartz-tungstene-halogeno (QTH) source and the collected beam is filtered to illuminate in different precise wavelength bands in the short wave domain.
We will use it on tonsil tissue just after tonsillectomy and just before the histological analysis.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- Tonsillectomy
- suspicion of Head-and neck cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient's tissues not exposed EndoSWIR Tonsil of each patient will not be imaged using the medical device Patient's tissues exposed EndoSWIR Tonsil of each patient will be imaged using the medical device
- Primary Outcome Measures
Name Time Method Tissue integrity 1 day Histological score : evaluation of cellular cohesion and denaturation of epithelial cells and conjunctive support tissue
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chu Grenoble Alpes
🇫🇷Grenoble Cedex 9, France