Safety Validation of EndoSWIR Device

NCT ID: NCT04274309

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-21

Study Completion Date

2021-05-01

Brief Summary

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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

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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

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Optical Guided Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient's tissues exposed

Tonsil of each patient will be imaged using the medical device

EndoSWIR

Intervention Type DEVICE

Exposition of the respected tissues to the camera

Patient's tissues not exposed

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

EndoSWIR

Intervention Type DEVICE

Exposition of the respected tissues to the camera

Interventions

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EndoSWIR

Exposition of the respected tissues to the camera

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Tonsillectomy

Exclusion Criteria

* suspicion of Head-and neck cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé et de la Recherche Médicale, Institute for Advanced Biosciences

UNKNOWN

Sponsor Role collaborator

Commissariat A L'energie Atomique

OTHER_GOV

Sponsor Role collaborator

Lynred

UNKNOWN

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian RIGHINI

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Chu Grenoble Alpes

Grenoble, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christian RIGHINI

Role: CONTACT

04 76 76 56 56 ext. +33

Noémie DUTRIEUX

Role: CONTACT

04 76 76 56 56 ext. +33

Facility Contacts

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Noémie DUTRIEUX

Role: primary

04767656 56 ext. +33

Other Identifiers

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2019-A03333-54

Identifier Type: OTHER

Identifier Source: secondary_id

38RC19.388

Identifier Type: -

Identifier Source: org_study_id

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