Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-09 @ 8:17 AM
Study NCT ID:
NCT03678220
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2018-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Augmented Reality in Minimally Invasive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2018-09-17', 'studyFirstSubmitQcDate': '2018-09-17', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgeon interview regarding usability', 'timeFrame': 'post surgery, an expected average of 5 minutes', 'description': 'The ease of use of the LapAR system will be evaluated by the surgeon'}, {'measure': 'Procedure time', 'timeFrame': 'during surgery', 'description': 'Time of using the LapAR system for laparoscopic hepatectomy and laparoscopic thermal ablation'}, {'measure': 'Measurement of margin', 'timeFrame': 'post surgery', 'description': 'Obtain from Pathology department or follow-up imaging'}], 'secondaryOutcomes': [{'measure': 'System set-up time', 'timeFrame': 'before surgery, an expected average of 15 min'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic Ultrasound'], 'conditions': ['Laparoscopic Hepatectomy', 'Laparoscopic Liver Thermal Ablation']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to test the technical feasibility of LapAR visualization system for guiding laparoscopic surgeries and to gather clinical feedback on the use of this tool.', 'detailedDescription': 'Surgeons use real-time video generated by a laparoscope to visualize the operative field when performing laparoscopic procedures. An inability to see beneath organ surfaces is a limitation of the current visualization technology. Surgeons additionally use laparoscopic ultrasound to see beneath organ surfaces, but also need to mentally correlate the ultrasound image with the video of the operative field. This process is difficult, subjective, and variable with expertise, and discourages the use of ultrasound.\n\nThe investigators have developed a method to combine live laparoscopic video and laparoscopic ultrasound images to present fused multimodality images on a single display, eliminating the need for mental image correlation. Specifically, the image fusion method, called laparoscopic augmented reality (LapAR), augments the laparoscopic video with ultrasound data when required by surgeons. This study is designed to test this minimal-risk capability in patients referred for relevant laparoscopic procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is referred for either laparoscopic partial hepatectomy for tumor removal or laparoscopic ablation of liver cancer;\n2. Patient must be at least 18 years old;\n3. Patient provides written consent;\n4. Patient is considered a suitable candidate based on tumor location for using the AR system.\n\nExclusion Criteria:\n\nPatients with pacemaker or any other ICD(intra-cardiac device) which may interfere with electromagnetic tracking'}, 'identificationModule': {'nctId': 'NCT03678220', 'briefTitle': 'Assessment of Augmented Reality in Minimally Invasive Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'IGI Technologies, Inc.'}, 'officialTitle': 'Clinical Translation of Augmented Reality Visualization for Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'LAPAR01'}, 'secondaryIdInfos': [{'id': '2R42CA192504', 'link': 'https://reporter.nih.gov/quickSearch/2R42CA192504', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients using LapAR system', 'interventionNames': ['Device: LapAR']}], 'interventions': [{'name': 'LapAR', 'type': 'DEVICE', 'description': 'LapAR system will be used for guidance during laparoscopic hepatectomy and laparoscopic liver thermal ablation', 'armGroupLabels': ['Patients using LapAR system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'David Geller, MD', 'role': 'CONTACT', 'email': 'gellerda@upmc.edu', 'phone': '412-692-2001'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Raj Shekhar, PhD', 'role': 'CONTACT', 'email': 'raj@igitechnologies.com', 'phone': '202-476-1201'}, {'name': 'William Plishker, PhD', 'role': 'CONTACT', 'email': 'will@igitechnologies.com', 'phone': '202-713-9571'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IGI Technologies, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'University of Pittsburgh Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}