NCT04274309

Safety Validation of EndoSWIR Device

Evaluation of the Medical Device ex Vivo ENDOSWIR in Patient Operated for a Tonsillectomy : a Preliminary Cohort Study Proof of Concept (ENDOSWIR-AMYG)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Optical Guided Surgery

Interventions

Type	Name	Description
DEVICE	EndoSWIR	Exposition of the respected tissues to the camera

Timeline

• Start date: 2020-07-21
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2020-02-18
• Last updated: 2020-07-23

Locations

1 site across 1 country: France