Optical Guided SurgeryENDO-AMYGNCT04274309
Safety Validation of EndoSWIR Device
An observational study of Optical Guided Surgery, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optical Guided Surgery
- What is being tested?
- EndoSWIR
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2020to 1 May 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men or Women more than 18
Who may be able to join
- Tonsillectomy
Who cannot join
- suspicion of Head-and neck cancer
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, 38043
Noémie DUTRIEUX, 04767656 56 ext. +33, ndutrieux@chu-grenoble.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Optical Guided Surgery
- Being tested
- EndoSWIR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoSWIRDevice
Exposition of the respected tissues to the camera
| Study group | Role | What they receive |
|---|---|---|
| Patient's tissues exposed | Tonsil of each patient will be imaged using the medical device Receives: Device: EndoSWIR | |
| Patient's tissues not exposed | Tonsil of each patient will not be imaged using the medical device Receives: Device: EndoSWIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue integrity
Histological score : evaluation of cellular cohesion and denaturation of epithelial cells and conjunctive support tissue
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start21 Jul 2020
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optical Guided SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé et de la Recherche Médicale, Institute for Advanced Biosciences, Commissariat A L'energie Atomique, Lynred
- Responsible party
- Sponsor
- Investigators
- Christian RIGHINI, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274309
- Sponsor's protocol ID
- 38RC19.388
- Other IDs
- 2019-A03333-54
- Acronym
- ENDO-AMYG
- Status last verified
- Jul 2020
- First submitted
- 14 Feb 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Medical Device ex Vivo ENDOSWIR in Patient Operated for a Tonsillectomy : a Preliminary Cohort Study Proof of Concept (ENDOSWIR-AMYG)
- ClinicalTrials.gov ID
- NCT04274309
- Acronym / sponsor ID
- ENDO-AMYG / 38RC19.388
- Conditions
- Optical Guided Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Institut National de la Santé et de la Recherche Médicale, Institute for Advanced Biosciences, Commissariat A L'energie Atomique, Lynred
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient's tissues exposed | – | Device: EndoSWIRTonsil of each patient will be imaged using the medical device |
| Patient's tissues not exposed | – | Device: EndoSWIRTonsil of each patient will not be imaged using the medical device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men or Women more than 18
Key inclusion criteria (1 listed)
- Tonsillectomy
Key exclusion criteria (1 listed)
- suspicion of Head-and neck cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoSWIRExposition of the respected tissues to the camera | Device | Patient's tissues exposed, Patient's tissues not exposed |
Primary outcome
Tissue integrity
Time frame: 1 day
Histological score : evaluation of cellular cohesion and denaturation of epithelial cells and conjunctive support tissue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian RIGHINI principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optical Guided Surgery, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian RIGHINI (04 76 76 56 56 ext. +33, crighini@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue integrity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020; AzTrials last refreshed its copy on 30 Oct 2026.