Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-30 @ 7:55 AM
Study NCT ID:
NCT04698668
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2021-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Outcomes and Performances of the Application of Augmented Reality in Operative Digestive Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-06', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical and radiological resolution of the PFC', 'timeFrame': '12 months', 'description': "complete emtying of the PFC tighter with resolution of patients' symptomps"}, {'measure': 'time of radiological resolution', 'timeFrame': '12 months', 'description': 'time taken for the complete emtying of the PFC'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pseudocyst', 'Walled Off Cavity']}, 'referencesModule': {'references': [{'pmid': '23100216', 'type': 'BACKGROUND', 'citation': 'Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.'}, {'pmid': '29631305', 'type': 'BACKGROUND', 'citation': 'Arvanitakis M, Dumonceau JM, Albert J, Badaoui A, Bali MA, Barthet M, Besselink M, Deviere J, Oliveira Ferreira A, Gyokeres T, Hritz I, Hucl T, Milashka M, Papanikolaou IS, Poley JW, Seewald S, Vanbiervliet G, van Lienden K, van Santvoort H, Voermans R, Delhaye M, van Hooft J. Endoscopic management of acute necrotizing pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) evidence-based multidisciplinary guidelines. Endoscopy. 2018 May;50(5):524-546. doi: 10.1055/a-0588-5365. Epub 2018 Apr 9.'}, {'pmid': '26826086', 'type': 'BACKGROUND', 'citation': 'Rajagopal M, Venkatesan AM. Image fusion and navigation platforms for percutaneous image-guided interventions. Abdom Radiol (NY). 2016 Apr;41(4):620-8. doi: 10.1007/s00261-016-0645-7.'}, {'pmid': '29954676', 'type': 'BACKGROUND', 'citation': 'Zhang H, Chen GY, Xiao L, Ma X, Shi L, Wang T, Yan HT, Zou H, Chen Q, Tang LJ, Liu WH. Ultrasonic/CT image fusion guidance facilitating percutaneous catheter drainage in treatment of acute pancreatitis complicated with infected walled-off necrosis. Pancreatology. 2018 Sep;18(6):635-641. doi: 10.1016/j.pan.2018.06.004. Epub 2018 Jun 18.'}, {'pmid': '23684089', 'type': 'BACKGROUND', 'citation': 'ASGE Standards of Practice Committee; Early DS, Acosta RD, Chandrasekhara V, Chathadi KV, Decker GA, Evans JA, Fanelli RD, Fisher DA, Fonkalsrud L, Hwang JH, Jue TL, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf RN, Shergill AK, Cash BD. Adverse events associated with EUS and EUS with FNA. Gastrointest Endosc. 2013 Jun;77(6):839-43. doi: 10.1016/j.gie.2013.02.018. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Virtual reality obtained by the fusion of images can be applied to several fields of medicine leading to the so called "augmented reality". Since 2017 investigators have been using a new digital angiographic system (Discovery IGS 40, General Electrics), where fluoroscopy can be fused with pre-procedural CT o MRI. Specifically the present study aimed at verifying the advantages that fusion imaging could bring in EUS-guided drainage of post-pancreatitis fluid collection (PFC), i.e. pseudocysts or WON, in terms of more appropriate visualization, drainage approach and time needed for resolution.', 'detailedDescription': "17 drainages performed with traditional radiology (group 1) were retrospectively compared with 14 ones achieved with the fusion approach (group 2). The two population were homogenous for age, sex, pancreatitis etiology and indication for drainage whereas PFCs of group 2 were larger (663 cm3 vs 437 cm3), more frequently WON than pseudocysts and were treated more precociously. As for procedure, in the group 2, thanks to fusion imaging, endoscopists didn't need ever contrast media - that was pivotal with traditional radiology - to adequately define lesion morphology. LAMS (Axios) stents were placed mainly in group 2, while in group 1 other types of stent were used."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient affected by moderate-severe pancreatits whio develops a PFC (WON or pseudocysts) that requires an endoscopic drainage', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with post-pancreatitis PCF endoscopically drained\n\nExclusion Criteria:\n\n* refuse to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT04698668', 'briefTitle': 'Evaluation of the Outcomes and Performances of the Application of Augmented Reality in Operative Digestive Endoscopy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Azienda USL Reggio Emilia - IRCCS'}, 'officialTitle': 'Fusion Radiology in Interventional Endoscopy (FRIEnd) Approach for Pancreatic Fluid Collections', 'orgStudyIdInfo': {'id': 'GASTRO.04.2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with pancreatic fluid collection treated with traditional EUS-drainage'}, {'label': '2', 'description': 'Patients with pancreatic fluid collection treated with fusion imaging', 'interventionNames': ['Device: fusion imaging']}], 'interventions': [{'name': 'fusion imaging', 'type': 'DEVICE', 'description': 'To drain a pancreatic fluid collection through the assitance of the CT-scan image that is superimposed on the radiological field', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reggio Emilia', 'state': 'RE', 'country': 'Italy', 'facility': 'IRCCS-AUSL Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}], 'overallOfficials': [{'name': 'Romano Sassatelli', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS-AUSL Reggio Emilia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda USL Reggio Emilia - IRCCS', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}