Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-29 @ 7:33 AM
Study NCT ID:
NCT06877559
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-14
First Post:
2025-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balloon-Assisted Enteroscopic Treatment for Phytobezoar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Balloon-Assisted Enteroscopic treatment for Phytobezoar', 'timeFrame': '3 months', 'description': 'Success Rate of the Procedure'}], 'secondaryOutcomes': [{'measure': 'Safety of Balloon-Assisted Enteroscopic treatment for Phytobezoar', 'timeFrame': '3 months', 'description': 'Incidence of Complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Phytobezoar; Intestine']}, 'descriptionModule': {'briefSummary': 'By reviewing a case series of patients who underwent balloon-assisted enteroscopic treatment for phytobezoar at our hospital, we analyzed the safety and efficacy of this technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with small intestinal phytobezoar', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Retrospectively collect data from patients who underwent balloon-assisted enteroscopic treatment for phytobezoar at our hospital.\n\nExclusion Criteria:\n\n* Patients with incomplete clinical data.'}, 'identificationModule': {'nctId': 'NCT06877559', 'briefTitle': 'Balloon-Assisted Enteroscopic Treatment for Phytobezoar', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Analysis of the Safety and Efficacy of Balloon-Assisted Enteroscopic Treatment for Phytobezoar', 'orgStudyIdInfo': {'id': '2025-SDU-Qilu-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who underwent balloon-assisted enteroscopic treatment for phytobezoar', 'description': 'Patient information was retrieved and collected through the HIS (Hospital Information System) and endoscopy system of Qilu Hospital of Shandong University, followed by statistical analysis. The collected information includes: gender, age, comorbid conditions, symptoms, time of onset, laboratory test results, time of small intestinal endoscopy, description of endoscopic procedures, success of the procedure, whether sodium bicarbonate was injected, presence of complications during treatment, length of hospital stay, and days from surgery to discharge.', 'interventionNames': ['Other: balloon-assisted enteroscopic treatment for phytobezoar']}], 'interventions': [{'name': 'balloon-assisted enteroscopic treatment for phytobezoar', 'type': 'OTHER', 'description': 'The endoscopists applied balloon-assisted enteroscopy for the treatment of the phytobezoar', 'armGroupLabels': ['Patients who underwent balloon-assisted enteroscopic treatment for phytobezoar']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu hospital of shandong university', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Xiuli Zuo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of gastroenterology department', 'investigatorFullName': 'Xiuli Zuo', 'investigatorAffiliation': 'Shandong University'}}}}