Clinical Trials Directory

Trials / Unknown

UnknownNCT04226781

ICG vs. HSI in Gastrointestinal Resections

Comparison Between Fluorescenceimaging With Indocyaningreen (ICG) and Hyperspectralimagig (HSI) for Tissue Perfusion in Gastrointestinal Resections

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
University of Leipzig · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

In this study, gastrointestinal anastomoses are examined with a hyperspectral camera and after this the investigators use the Standard Routine ICG-Imaging. At the end, both methods will be compared..

Detailed description

All gastrointestinal anastomoses were examined in all patients with written informed consent. As Standard in our clinical Routine the tissue perfusion is measured with fluorescence Imaging and Indocyaningreen (ICG). In this study the investigators use the Hyperspectral-Camera (HSI-Camera) as new method. The measurements were performed like described before, using the TIVITA Tissue system (Diaspective Vision GmbH, Am Salzhaff, Germany). 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. This work is focused on tissue oxygenation (StO2), which represents the relative blood oxygenation in the microcirculation of superficial tissue layers (approximately 1 mm) and the near-infrared (NIR) Perfusion Index, representing tissue layers in 4-6 mm penetration depth. As Standard method ICG-Fluorescence Imaging is used. After the procedure the Perfusion data of both Systems is compared.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTHyperspectral-ImagingPhotos were taken with the hyperspectral camera of the gastrointestinal anastomosis.
DIAGNOSTIC_TESTIndocyaningreen-Fluorescence imagingPhotos were taken with the Fluorescence camera after injection of the indocyaningreen-dye of the gastrointestinal anastomosis

Timeline

Start date
2020-01-02
Primary completion
2020-12-31
Completion
2021-06-20
First posted
2020-01-13
Last updated
2020-03-16

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT04226781. Inclusion in this directory is not an endorsement.