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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04274309
Acronym
ENDO-AMYG
Enrollment
10
Registered
2020-02-18
Start date
2020-07-21
Completion date
2021-05-01
Last updated
2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optical Guided Surgery

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.

Interventions

DEVICEEndoSWIR

Exposition of the respected tissues to the camera

Sponsors

Institut National de la Santé et de la Recherche Médicale, Institute for Advanced Biosciences
CollaboratorUNKNOWN
Commissariat A L'energie Atomique
CollaboratorOTHER_GOV
Lynred
CollaboratorUNKNOWN
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Tonsillectomy

Exclusion criteria

* suspicion of Head-and neck cancer

Design outcomes

Primary

MeasureTime frameDescription
Tissue integrity1 dayHistological score : evaluation of cellular cohesion and denaturation of epithelial cells and conjunctive support tissue

Countries

France

Contacts

Primary ContactChristian RIGHINI
crighini@chu-grenoble.fr04 76 76 56 56
Backup ContactNoémie DUTRIEUX
ndutrieux@chu-grenoble.fr04 76 76 56 56

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026