An interventional study of Hyperspectral Imaging in Surgical Anastomosis, sponsored by University of Leipzig. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-31.
Sponsored by University of Leipzig · Not applicable, Interventional, and Diagnostic
In this study, gastrointestinal anastomoses are examined with a hyperspectral camera.
The anastomoses were examined under standardized conditions directly after creation. 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). The distance between camera and object was 30 cm for all measurements. The Number of Effective Pixels at this distance is 640 × 480 (x-, y-axis. The resulting field of view (FOV) has the dimensions 6.4 × 4.8 cm2 and a spatial resolution of 0.1 mm/pixel. The FOV is illuminated by 8 halogen spots (20 W each). The ceiling lights and other light sources were switched off, to avoid artifacts during the measurement (approximately 10 seconds). 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.
University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.
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diagnostic hyperspectral Imaging of the gastrointestinal anastomosis and calculating the anastomotic Perfusion measures
Procedure: Hyperspectral Imaging
Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.
Anastomotic Perfusion: (Oxygenation (StO2)
Oxygenation (StO2) in %: Relative O2 saturation of the blood immicrocircular system in superficial tissue layers (penetration depth: approx. 1 mm)
Time frame: direct during the Operation (ca. 15-20 Minutes)
Anastomotic Perfusion: Tissue-Hemoglobin index
Tissue Hemoglobin index in %: Existing hemoglobin distribution in the microcircular system of the tissue area under consideration (index value)
Time frame: direct during the Operation (ca. 15-20 Minutes)
Anastomotic Perfusion: Near Infrared Perfusion Index
Near Infrared Perfusion Index in %: Relative O2 saturation of the blood immicrocircular system in deeper tissue layers (penetration depth: 4-6mm; index value)
Time frame: direct during the Operation (ca. 15-20 Minutes)
Anastomotic Perfusion: Tissue-Water-Index
Tissue-Water-Index in %: Existing water distribution in the tissue area under consideration (index value)
Time frame: direct during the Operation (ca. 15-20 Minutes)
Plan to share: No — no sharing
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University of Leipzig