Tissue Characterization With Hyperspectral Imaging (HSI) (HSIT)

September 10, 2020 updated by: Dr. Boris Jansen-Winkeln, University of Leipzig

Tissue Characterisation With Hyperspectral Imaging Methods

Hyperspectral Imaging (HSI) is a contact free method to analyse the from the tissue reflected light in the range of 500-1000nm. Aim of the study is to identify special reflex patterns to identify special tissue

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This HSI-camera provides hyperspectral images with a high spectral resolution (5 nm) in the visible and near infrared range (500-1000 nm). A RGB image and 4 false color images that represent physiologic parameters are intraoperatively provided by an analysis software. But after the procedure all spectral datasets could be investigated. To analyse and differentiate the different tissues, a catalog database is needed of all tissues including Tumors.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig - AöR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients with surgical procedure

Exclusion Criteria:

  • inability to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperspectral imaging
diagnostic hyperspectral imaging of the human tissue an correlation with local blood parameters and local pathological examination
Procedure: Hyperspectral imaging
Photos were taken with the hyperspectral camera of the human tissue
Other Names:
  • Marking of the target region (Suture/Clip/ink)
Diagnostic test: Lactate acid measurement
At the marked regions of the specimen, a lactate acid measurement was performed.
Diagnostic test: pathological examination
At the marked regions of the specimen, the pathological examination was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor detection with HSI
Time Frame: direct during the Operation (ca. 15-20 Minutes)
Due to the non-invasive diagnostics with the HSI camera, tumor tissue can be distinguished from healthy tissue.
direct during the Operation (ca. 15-20 Minutes)
Tissue recognition with HSI
Time Frame: after the operation within 24 hours
different tissues can be differentiated from each other with HSI
after the operation within 24 hours
Inflammatory classification with HSI
Time Frame: after the operation within 24 hours
Classification of the grade of the inflammation e.g. in IBD
after the operation within 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue perfusion
Time Frame: direct during the Operation (ca. 10-15 Minutes)
Tissue perfusion in the upper and lower tissue layers measured with the HSI Camera
direct during the Operation (ca. 10-15 Minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Study Director: Ines Gockel, MD, Prof., University of Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2019

Primary Completion (Anticipated)

January 2, 2022

Study Completion (Anticipated)

June 2, 2022

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 13, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201905

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

no sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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