Safety Validation of EndoSWIR Device (ENDO-AMYG)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Optical Guided Surgery

Treatments: Device: EndoSWIR

Study type: Observational

Funder types: Other

Identifiers

NCT04274309

2019-A03333-54 (Other Identifier)

38RC19.388

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Tonsillectomy

Exclusion criteria

• suspicion of Head-and neck cancer

Trial design

10 participants in 2 patient groups

Patient's tissues exposed

Description:

Tonsil of each patient will be imaged using the medical device

Treatment:

Device: EndoSWIR

Patient's tissues not exposed

Description:

Tonsil of each patient will not be imaged using the medical device

Treatment:

Device: EndoSWIR