Safety Validation of EndoSWIR Device | NCT04274309

Studies
Safety Validation of EndoSWIR Device

NCT04274309

Sponsor

University Hospital, Grenoble

Status

Unknown status

Last Update Posted

Jul 23, 2020Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Optical Guided Surgery

Interventions

EndoSWIR

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-A03333-54	Other Identifier	ID RCB

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 21, 2020Actual

Primary Completion Date

May 1, 2021Estimated

Completion Date

May 1, 2021Estimated

First Submitted Date

Feb 14, 2020

First Submission Date that Met QC Criteria

Feb 14, 2020

First Posted Date

Feb 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2020

Last Update Posted Date

Jul 23, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University Hospital, GrenobleOTHER

Collaborators

Name	Class
Institut National de la Santé et de la Recherche Médicale, Institute for Advanced Biosciences	UNKNOWN
Commissariat A L'energie Atomique	OTHER_GOV
Lynred	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient's tissues exposed		Tonsil of each patient will be imaged using the medical device	Device: EndoSWIR
Patient's tissues not exposed		Tonsil of each patient will not be imaged using the medical device	Device: EndoSWIR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EndoSWIR	Device	Exposition of the respected tissues to the camera	Patient's tissues exposed Patient's tissues not exposed

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Tonsillectomy

Exclusion Criteria:

suspicion of Head-and neck cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Men or Women more than 18

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christian RIGHINI	Contact	04 76 76 56 56	+33	crighini@chu-grenoble.fr
Noémie DUTRIEUX	Contact	04 76 76 56 56	+33	ndutrieux@chu-grenoble.fr

Overall Officials

Name	Affiliation	Role
Christian RIGHINI	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Grenoble Alpes	Recruiting	Grenoble		38043	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided