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Tissue Characterization With Hyperspectral Imaging (HSI) (HSIT)

Primary Purpose

Tissue Perfusion, Tumor, Inflammation

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hyperspectral imaging
Lactate acid measurement
pathological examination
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tissue Perfusion focused on measuring hyperspectral imaging, tissue detection, tumor detection, infammatory bowel disease, colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All patients with surgical procedure

Exclusion Criteria:

  • inability to consent

Sites / Locations

  • Universitätsklinikum Leipzig - AöRRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperspectral imaging

Arm Description

diagnostic hyperspectral imaging of the human tissue an correlation with local blood parameters and local pathological examination

Outcomes

Primary Outcome Measures

Tumor detection with HSI
Due to the non-invasive diagnostics with the HSI camera, tumor tissue can be distinguished from healthy tissue.
Tissue recognition with HSI
different tissues can be differentiated from each other with HSI
Inflammatory classification with HSI
Classification of the grade of the inflammation e.g. in IBD

Secondary Outcome Measures

Tissue perfusion
Tissue perfusion in the upper and lower tissue layers measured with the HSI Camera

Full Information

First Posted
January 13, 2020
Last Updated
September 10, 2020
Sponsor
University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT04230603
Brief Title
Tissue Characterization With Hyperspectral Imaging (HSI)
Acronym
HSIT
Official Title
Tissue Characterisation With Hyperspectral Imaging Methods
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
January 2, 2022 (Anticipated)
Study Completion Date
June 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tissue Perfusion, Tumor, Inflammation, Inflammatory Bowel Diseases
Keywords
hyperspectral imaging, tissue detection, tumor detection, infammatory bowel disease, colorectal cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperspectral imaging
Arm Type
Experimental
Arm Description
diagnostic hyperspectral imaging of the human tissue an correlation with local blood parameters and local pathological examination
Intervention Type
Procedure
Intervention Name(s)
Hyperspectral imaging
Other Intervention Name(s)
Marking of the target region (Suture/Clip/ink)
Intervention Description
Photos were taken with the hyperspectral camera of the human tissue
Intervention Type
Diagnostic Test
Intervention Name(s)
Lactate acid measurement
Intervention Description
At the marked regions of the specimen, a lactate acid measurement was performed.
Intervention Type
Diagnostic Test
Intervention Name(s)
pathological examination
Intervention Description
At the marked regions of the specimen, the pathological examination was performed.
Primary Outcome Measure Information:
Title
Tumor detection with HSI
Description
Due to the non-invasive diagnostics with the HSI camera, tumor tissue can be distinguished from healthy tissue.
Time Frame
direct during the Operation (ca. 15-20 Minutes)
Title
Tissue recognition with HSI
Description
different tissues can be differentiated from each other with HSI
Time Frame
after the operation within 24 hours
Title
Inflammatory classification with HSI
Description
Classification of the grade of the inflammation e.g. in IBD
Time Frame
after the operation within 24 hours
Secondary Outcome Measure Information:
Title
Tissue perfusion
Description
Tissue perfusion in the upper and lower tissue layers measured with the HSI Camera
Time Frame
direct during the Operation (ca. 10-15 Minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients with surgical procedure Exclusion Criteria: inability to consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boris Jansen-Winkeln, MD, PD
Phone
+49-314-97
Ext
17200
Email
boris.jansen-winkeln@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name or Official Title & Degree
Ines Gockel, MD, Prof.
Phone
+49-314-97
Ext
17200
Email
ines.gockel@medizin.uni-leipzig.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ines Gockel, MD, Prof.
Organizational Affiliation
University of Leipzig
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinikum Leipzig - AöR
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris Jansen-Winkeln, MD, PD
Phone
+49-341-97-
Ext
17200
Email
boris.jansen-winkeln@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Ines Gockel, MD, Prof.
Phone
+49-341-97-
Ext
17200
Email
ines.gockel@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Boris Jansen-Winkeln, MD, PD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no sharing

Learn more about this trial

Tissue Characterization With Hyperspectral Imaging (HSI)

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