Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 6:25 PM
Study NCT ID:
NCT06027060
Status:
SUSPENDED
Last Update Posted:
2025-10-02
First Post:
2023-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study on Monitoring NSAID-Induced Gastropathy in Patients Using Magnetically-Controlled Capsule Gastroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Failure of equipment', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-27', 'studyFirstSubmitDate': '2023-08-30', 'studyFirstSubmitQcDate': '2023-08-30', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric diseases detected', 'timeFrame': '1 day', 'description': 'Gastric diseases detected'}], 'secondaryOutcomes': [{'measure': 'Gastric mucosal injury by Lanza score', 'timeFrame': '1 day', 'description': 'Gastric mucosal injury by Lanza score'}, {'measure': 'Gastric transit time', 'timeFrame': '1 day', 'description': 'Gastric transit time'}, {'measure': 'Gastric cleanliness', 'timeFrame': '1 day', 'description': 'Gastric cleanliness'}, {'measure': 'Effects of NSAID duration on gastric injury', 'timeFrame': '1 day', 'description': 'Effects of NSAID duration on gastric injury'}, {'measure': 'Effects of NSAID dosage on gastric injury', 'timeFrame': '1 day', 'description': 'Effects of NSAID dosage on gastric injury'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Magnetically-controlled Capsule Endoscopy'], 'conditions': ['NSAID-Associated Gastropathy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to observe gastric mucosal injuries in NSAID and non-NSAID users with magnetically-controlled capsule gastroscopy, and explore the effects of NSAIDs on gastric mucosal damage.', 'detailedDescription': 'Non-steroidal anti-inflammatory drugs are widely used in all kinds of people in China. A major limitation to their use is the adverse effects they cause on the gastrointestinal tract, including the formation of stomach lesions, ulcers due to stress reactions, and damage to the healing of gastric ulcers. The purpose of this prospective, single-center study was to monitor the gastric mucosal injury in patients with and without NSAIDs using magnetron capsule gastroscopy, and to explore the effect of NSaids on gastric mucosal injury.\n\nFor people taking NSAIDs, it is necessary to regularly detect gastric mucosal damage, and timely intervention treatment is required if relevant lesions are found, and the medication plan is adjusted. Magnetron capsule gastroscope has the advantages of comfort, safety, no anesthesia, no risk of cross infection, etc. It is highly accepted by the population, and is a beneficial supplement to traditional gastroscopy, so that some people with absolute or relative contraindications of traditional gastroscopy can get timely endoscopy, and can be diagnosed and treated early.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ninety patients receiving NSAIDS (more than 3 months) and undergoing magnetron capsule gastroscopy at Renji Hospital were included, and 90 patients not taking NSAIDS and undergoing magnetron capsule gastroscopy at the same time were included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned magnetically-controlled capsule gastroscopy\n* NSAID use \\>3 months or no NSAID use\n* Informed consent\n\nExclusion Criteria:\n\n* No surgical conditions or refuses abdominal surgery (Once the capsule is stuck it cannot be removed surgically);\n* Cardiac pacemakers (except MRI-compatible ones);\n* Electronic implants or metal foreign bodies;\n* Pregnant women;\n* Known or suspected GI obstruction, stenosis, fistula;\n* Dysphagia.'}, 'identificationModule': {'nctId': 'NCT06027060', 'briefTitle': 'Observational Study on Monitoring NSAID-Induced Gastropathy in Patients Using Magnetically-Controlled Capsule Gastroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Observational Study on Monitoring NSAID-Induced Gastropathy in Patients Using Magnetically-Controlled Capsule Gastroscopy', 'orgStudyIdInfo': {'id': 'Renjixh202301'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NSAIDs users', 'description': '90 patients taking NSAIDs for over 3 months'}, {'label': 'non-NSAIDs users', 'description': '90 non-NSAIDs users undergoing physical examination'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200001', 'city': 'Shanghai', 'country': 'China', 'facility': 'Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Xiaobo Li', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}