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Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment

NCT04589884 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 112

Last updated 2024-01-09

No results posted yet for this study

Summary

The intraoperative recognition of target structures, which need to be preserved or selectively removed, is of paramount importance during surgical procedures. This task relies mainly on the anatomical knowledge and experience of the operator. Misperception of the anatomy can have devastating consequences. Hyperspectral imaging (HSI) represents a promising technology that is able to perform a real-time optical scanning over a large area, providing both spatial and spectral information. HSI is an already established method of objectively classifying image information in a number of scientific fields (e.g. remote sensing).

Our group recently employed HSI as intraoperative tool in the porcine model to quantify perfusion of the organs of the gastrointestinal tract against robust biological markers. Results showed that this technology is able to quantify bowel blood supply with a high degree of precision. Hyperspectral signatures have been successfully used, coupled to machine learning algorithms, to discriminate fine anatomical structures such as nerves or ureters intraoperatively (unpublished data).

The i-EX-MACHYNA3 study aims at translating the HSI technology in combination with several deep learning algorithms to differentiate among different classes of human tissues (including key anatomical structures such as BD, nerves and ureters).

Conditions

  • Parathyroid Diseases
  • Thyroid Diseases
  • Liver Cancer
  • Liver Metastases
  • Digestive Cancer
  • Digestive Perfusion

Interventions

OTHER

Hyperspectral Imaging

Hyperspectral images of the operative field will be collected at several time points during the surgical procedure. The device used is the TIVITA® compact Hyperspectral imaging system (Diaspective Vision GmbH, Germany). It is a CE (European Economic Area) mark approved device. The acquisition takes roughly 10 seconds, is contrast-free and contact-free.

Sponsors & Collaborators

  • ARC Foundation for Cancer Research

    collaborator OTHER

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Michele DIANA, MD, PhD · Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-22
Primary Completion
2021-10-15
Completion
2021-10-15

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04589884 on ClinicalTrials.gov