Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT06725056
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-10
First Post:
2024-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-07', 'studyFirstSubmitDate': '2024-10-19', 'studyFirstSubmitQcDate': '2024-12-07', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sensitivity of DS-MCE in detection active bleeding and bleeding lesions, using the detection of EGD as the gold standard,', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks', 'description': 'Active bleeding is defined as the continuous flow of visible blood from damaged blood vessels under the microscope.\n\nThe detection results of bleeding lesions are divided into three categories: P0 refers to lesions without possible bleeding, such as visible submucosal veins, diverticula without bleeding traces, nodules without mucosal damage traces, etc; P1 refers to low-risk bleeding lesions, such as isolated erythema, isolated small erosions, or mucosal damage; P2 refers to high-risk bleeding lesions, such as peptic ulcers (active bleeding or visible blood vessels) with persistent or rebleeding risks, erosions with a diameter of ≥ 2mm, tumors, varicose veins, etc.'}], 'secondaryOutcomes': [{'measure': 'The specificity of ds MCE in detecting active bleeding and bleeding lesions using EGD as the gold standard', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}, {'measure': 'The number of observed signs of bleeding', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}, {'measure': 'Detection rate of bleeding lesions in enrolled subjects', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}, {'measure': 'Detection rate of lesions in enrolled subjects', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}, {'measure': 'The time from the admission of subjects to the detection of bleeding lesions', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}, {'measure': 'Number of therapeutic interventions (endoscopy, DSA, surgery) for enrolled subjects', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}, {'measure': 'The time from the admission of subjects to the start of therapeutic interventions (endoscopy, DSA, surgery)', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}, {'measure': 'Detection rate of esophageal, gastric, and small intestinal lesions in enrolled subjects', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}, {'measure': 'Time of traditional electronic gastroscopy examination', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}, {'measure': 'Time of DS-MCE examination', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}, {'measure': 'Incidence of rebleeding in enrolled subjects 30 days after discharge', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}, {'measure': 'Rate of all-cause mortality among enrolled subjects within 30 days of discharge', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}, {'measure': 'Time of hospital stay for enrolled subjects', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}, {'measure': 'Satisfaction of enrolled subjects', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks', 'description': 'use a certain scale named satisfaction scale to measure the satisfaction of enrolled subjects (0-36), lower scores mean a better outcome.'}, {'measure': 'clinical safety (Incidence of Treatment-Emergent Adverse Events, Safety and Tolerability)', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks', 'description': 'use the incidence of adverse events to measure clinical safety'}, {'measure': 'complication rate', 'timeFrame': 'From enrollment to the end of end of follow-up at 4 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AUGIB', 'DS-MCE', 'emergency department'], 'conditions': ['Acute Upper Gastrointestinal Bleeding', 'Capsule Endoscopes']}, 'descriptionModule': {'briefSummary': 'Use CE for pre-examination of patients with AUGIB symptoms in emergency centers may reduce the need for emergency electronic gastroscopy and have certain advantages in clinical work. Patients with low-risk lesions can be discharged without the need for EGD and hospitalization, greatly improving the utilization of medical resources.', 'detailedDescription': 'The investigators plan to conduct exploratory research by sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics, using EGD as the gold standard to evaluate the sensitivity of DS-MCE in diagnosing upper gastrointestinal bleeding lesions and active bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No gender limit, age ≥ 18 years\n* Presenting to the emergency department with melena or hematemesis\n* Hemodynamically stable at presentation\n* No endoscopic examination has been performed due to this bleeding\n* Agree to participate in this clinical trial and sign an informed consent form\n\nExclusion Criteria:\n\n* Patients with acute active massive bleeding or hemodynamic instability (blood pressure \\< 90 mmHg and heart rate \\> 120 beats per minute)\n* Patients with Hematochezia\n* Hemodynamics remained unstable after fluid resuscitation\n* Known or suspected intestinal obstruction, stenosis, or fistula\n* Severe motor disorders such as asthma, swallowing disorders, or gastric paralysis\n* History of abdominal surgery that affects the normal structure of the digestive tract in the past\n* When capsule retention occurs, the problem cannot be solved through surgery due to subjective or objective reasons\n* Implantable medical devices such as pacemakers, electronic cochlear implants, drug infusion pumps, and neural stimulators are installed inside the body, except for MRI compatible products\n* Pregnant women\n* Those who require MRI examination before capsule endoscopy discharge\n* Suffering from severe cardiovascular and pulmonary diseases (such as severe myocardial infarction, arrhythmia, heart failure, and respiratory failure)\n* Refuse MCE or gastroscopy examination\n* The researchers believe that the subjects have any other factors that are not suitable for participation in the study'}, 'identificationModule': {'nctId': 'NCT06725056', 'briefTitle': 'Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Detachable String Magnetically Controlled Capsule Endoscopy for Patients with Acute Upper Gastrointestinal Bleeding: a Prospective Study', 'orgStudyIdInfo': {'id': 'DS-MCE for patients with AUGIB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group of participants', 'description': 'Sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics, using EGD as the gold standard to evaluate the sensitivity of DS-MCE in diagnosing upper gastrointestinal bleeding lesions and active bleeding.', 'interventionNames': ['Other: DS-MCE and EGD examinations']}], 'interventions': [{'name': 'DS-MCE and EGD examinations', 'type': 'OTHER', 'description': 'sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics', 'armGroupLabels': ['group of participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Zhuan Liao', 'role': 'CONTACT', 'email': 'zhuanleo@126.com', 'phone': '+86 13061921980'}], 'facility': 'Changhai hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yilin Han', 'role': 'CONTACT', 'email': 'hanyl10@163.com', 'phone': '+8615038655111'}], 'overallOfficials': [{'name': 'Zhuan Liao', 'role': 'STUDY_CHAIR', 'affiliation': 'Changhai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhuan Liao', 'investigatorAffiliation': 'Changhai Hospital'}}}}