Safety Validation of EndoSWIR Device (ENDO-AMYG)

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

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.

Study Overview

• Status: Unknown
• Conditions: Optical Guided Surgery
• Intervention / Treatment: Device: EndoSWIR

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.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• France
  • Grenoble Cedex 9, France, 38043
    • Recruiting
    • Chu Grenoble Alpes
    • Contact: Noémie DUTRIEUX; Phone Number: +33 04767656 56; Email: ndutrieux@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Men or Women more than 18

Description

Inclusion Criteria:

• Tonsillectomy

Exclusion Criteria:

• suspicion of Head-and neck cancer

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient's tissues exposed; Tonsil of each patient will be imaged using the medical device	Device: EndoSWIR; 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	Device: EndoSWIR; Exposition of the respected tissues to the camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue integrity	Histological score : evaluation of cellular cohesion and denaturation of epithelial cells and conjunctive support tissue	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Commissariat A L'energie Atomique; Institut National de la Santé et de la Recherche Médicale, Institute for Advanced Biosciences; Lynred
• Investigators: Principal Investigator: Christian RIGHINI, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 38RC19.388; 2019-A03333-54 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No