Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-26 @ 7:06 AM
Study NCT ID:
NCT06020859
Status:
UNKNOWN
Last Update Posted:
2023-09-01
First Post:
2023-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MCE-new for Detection of Gastric Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-30', 'studyFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2023-08-30', 'lastUpdatePostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the degree of gastric mucosal visualization', 'timeFrame': '2 weeks', 'description': 'The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, \\<70% of the gastric mucosa can be observed.'}], 'secondaryOutcomes': [{'measure': 'The time of gastric examination', 'timeFrame': '2 weeks', 'description': 'The total time MCE required to complete the stomach examination'}, {'measure': 'detection of lesions', 'timeFrame': '2 weeks', 'description': 'The detection of gastric lesions by MCE'}, {'measure': 'Equipment operation evaluation', 'timeFrame': '2 weeks', 'description': "Operation fluency is defined as the smooth response between operation and real-time capsule shooting. Stability is defined as the stable ability to control the capsule in a fixed position; Comfort is defined as the operator's operating comfort during examination. They were all rated on a scale of 1-5, with 1 being the worst and 5 the best"}, {'measure': 'Safety Assessment', 'timeFrame': '2 weeks', 'description': 'Number and incidence of device-related adverse events and serious adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Capsule Endoscopy']}, 'referencesModule': {'references': [{'pmid': '30005825', 'type': 'BACKGROUND', 'citation': 'Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11.'}, {'pmid': '27211503', 'type': 'BACKGROUND', 'citation': 'Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.'}]}, 'descriptionModule': {'briefSummary': 'Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial', 'detailedDescription': 'The aim of this study is to investigate the effectiveness and safety of using a new MCE system for routine gastric examination and automatic scanning. This study is a prospective, self controlled clinical trail, which includes adult patients who plan to undergo MCE examination. Patients will undergo three different tests during the experiment: NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine gastric examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* underwent gastric examination;\n* At least 18 years old；\n* Be able to provide informed consent.\n\nExclusion Criteria:\n\n* With swallowing obstruction or disorders;\n* With known or suspected gastrointestinal obstruction, stenosis and fistula;\n* Have no conditions for surgery or refuse to undergo any abdominal surgery;\n* Be allergic to or have other known contraindication or intolerance to the drug used in the study;\n* With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies;\n* Women during pregnancy;\n* Currently enrolled in another clinical trial of a drug or device;\n* Other conditions determined by the investigator to be inappropriate for enrollment.'}, 'identificationModule': {'nctId': 'NCT06020859', 'briefTitle': 'MCE-new for Detection of Gastric Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'New MCE System for Detection of Gastric Lesions', 'orgStudyIdInfo': {'id': 'MCE-new'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NaviEC-2000Pro Gastro Scan', 'description': 'NaviEC-2000Pro Gastro Scan is a new mode of NaviEC-2000Pro', 'interventionNames': ['Device: undergo NaviEC-2000Pro Gastro Scan mode']}, {'type': 'EXPERIMENTAL', 'label': 'NaviEC-2000Pro Routine gastric examination', 'description': 'NaviEC-2000Pro Routine gastric examination is a mode of NaviEC-2000Pro', 'interventionNames': ['Device: NaviEC-2000Pro Routine gastric examination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NaviEC-1000 Routine gastric examination', 'description': 'NaviEC-1000 Routine gastric examination is a mode of NaviEC-1000', 'interventionNames': ['Device: NaviEC-1000 Routine gastric examination']}], 'interventions': [{'name': 'undergo NaviEC-2000Pro Gastro Scan mode', 'type': 'DEVICE', 'description': 'Patients undergo NaviEC-2000Pro Gastro Scan mode.', 'armGroupLabels': ['NaviEC-2000Pro Gastro Scan']}, {'name': 'NaviEC-2000Pro Routine gastric examination', 'type': 'DEVICE', 'description': 'Patients undergo NaviEC-2000Pro Routine gastric examination mode.', 'armGroupLabels': ['NaviEC-2000Pro Routine gastric examination']}, {'name': 'NaviEC-1000 Routine gastric examination', 'type': 'DEVICE', 'description': 'Patients undergo NaviEC-1000 Routine gastric examination mode.', 'armGroupLabels': ['NaviEC-1000 Routine gastric examination']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhuan Liao', 'role': 'CONTACT', 'email': 'liaozhuan@smmu.edu.cn', 'phone': '86-21-31161004'}, {'name': 'Yangyang Qian', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhuan Liao', 'investigatorAffiliation': 'Changhai Hospital'}}}}