Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-24 @ 3:00 AM
Study NCT ID:
NCT03667950
Status:
UNKNOWN
Last Update Posted:
2019-10-31
First Post:
2018-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081862', 'term': 'Hyperspectral Imaging'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-29', 'studyFirstSubmitDate': '2018-08-30', 'studyFirstSubmitQcDate': '2018-09-10', 'lastUpdatePostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anastomotic Perfusion: (Oxygenation (StO2)', 'timeFrame': 'direct during the Operation (ca. 15-20 Minutes)', 'description': 'Oxygenation (StO2) in %: Relative O2 saturation of the blood immicrocircular system in superficial tissue layers (penetration depth: approx. 1 mm)'}, {'measure': 'Anastomotic Perfusion: Tissue-Hemoglobin index', 'timeFrame': 'direct during the Operation (ca. 15-20 Minutes)', 'description': 'Tissue Hemoglobin index in %: Existing hemoglobin distribution in the microcircular system of the tissue area under consideration (index value)'}, {'measure': 'Anastomotic Perfusion: Near Infrared Perfusion Index', 'timeFrame': 'direct during the Operation (ca. 15-20 Minutes)', 'description': 'Near Infrared Perfusion Index in %: Relative O2 saturation of the blood immicrocircular system in deeper tissue layers (penetration depth: 4-6mm; index value)'}, {'measure': 'Anastomotic Perfusion: Tissue-Water-Index', 'timeFrame': 'direct during the Operation (ca. 15-20 Minutes)', 'description': 'Tissue-Water-Index in %: Existing water distribution in the tissue area under consideration (index value)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anastomotic perfusion, tissue oxygen saturation'], 'conditions': ['Surgical Anastomosis']}, 'referencesModule': {'references': [{'pmid': '29637244', 'type': 'BACKGROUND', 'citation': 'Jansen-Winkeln B, Maktabi M, Takoh JP, Rabe SM, Barberio M, Kohler H, Neumuth T, Melzer A, Chalopin C, Gockel I. [Hyperspectral imaging of gastrointestinal anastomoses]. Chirurg. 2018 Sep;89(9):717-725. doi: 10.1007/s00104-018-0633-2. German.'}]}, 'descriptionModule': {'briefSummary': 'In this study, gastrointestinal anastomoses are examined with a hyperspectral camera.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all gastrointestinal anastomoses\n\nExclusion Criteria:\n\n* inability to consent'}, 'identificationModule': {'nctId': 'NCT03667950', 'acronym': 'HSIGI', 'briefTitle': 'Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Vascular Border Zone Definition Using Intraoperative Hyperspectral Imaging for Resections and Reconstructions in Diseases of the Esophagus, Stomach, Pancreas, Small Intestine, Large Intestine and Rectum to Optimize Anastomotic Healing', 'orgStudyIdInfo': {'id': 'HSIGI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hyperspectral imaging', 'description': 'diagnostic hyperspectral Imaging of the gastrointestinal anastomosis and calculating the anastomotic Perfusion measures', 'interventionNames': ['Procedure: Hyperspectral Imaging']}], 'interventions': [{'name': 'Hyperspectral Imaging', 'type': 'PROCEDURE', 'description': 'Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.', 'armGroupLabels': ['hyperspectral imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig - AöR', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'centralContacts': [{'name': 'Boris Jansen-Winkeln, Dr.', 'role': 'CONTACT', 'email': 'boris.jansen-winkeln@medizin.uni-leipzig.de', 'phone': '+49-314-97', 'phoneExt': '17200'}, {'name': 'Ines Gockel, Prof. Dr.', 'role': 'CONTACT', 'email': 'ines.gockel@medizin.uni-leipzig.de'}], 'overallOfficials': [{'name': 'Boris Jansen-Winkeln, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leipzig'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Dr. Boris Jansen-Winkeln', 'investigatorAffiliation': 'University of Leipzig'}}}}