Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 9:53 AM
Study NCT ID:
NCT04917367
Status:
RECRUITING
Last Update Posted:
2022-03-24
First Post:
2021-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnosis and Treatment of Foreign Bodies Outside Pharynx and Esophagus Lumen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-05-08', 'releaseDate': '2023-11-24'}], 'estimatedResultsFirstSubmitDate': '2023-11-24'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2021-06-07', 'lastUpdatePostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate', 'timeFrame': '5 years', 'description': 'Success rate of two groups'}], 'secondaryOutcomes': [{'measure': 'surgery time', 'timeFrame': 'intraoperative', 'description': 'Surgery time of two groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migrating foreign body; Upper aerodigestive tract; Neck; Laryngoscopy endoscopy; Positioning'], 'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'Objective: To improve the success rate of the treatment of migrating foreign bodies in the upper aerodigestive tract.\n\nMethods: The medical records of inpatients conforming to the diagnosis of migrating foreign bodies between 2020 and 2025 were reviewed. Data regarding age, gender, time from onset to hospitalization, computed tomography (CT) and endoscopic scans, surgical procedures，and follow-up were collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People from vulnerable groups are excluded', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The foreign body of pharynx or esophagus was confirmed by surgical exploration\n\nExclusion Criteria:\n\n* The foreign body is in the pharynx or esophagus or is not found during surgery.'}, 'identificationModule': {'nctId': 'NCT04917367', 'briefTitle': 'Diagnosis and Treatment of Foreign Bodies Outside Pharynx and Esophagus Lumen', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Second Affiliated Hospital, College of Medicine, Zhejiang University', 'orgStudyIdInfo': {'id': '2020-152'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conventional surgery group', 'description': 'Conventional surgery with Preoperative foreign body localization', 'interventionNames': ['Procedure: exploratory surgery']}, {'label': 'New surgery group', 'description': 'new surgery with Intraoperative localization of foreign body', 'interventionNames': ['Procedure: exploratory surgery']}], 'interventions': [{'name': 'exploratory surgery', 'type': 'PROCEDURE', 'otherNames': ['lateral cervical incision surgery'], 'description': 'For foreign bodies in the retropharyngeal space or parapharyngeal space above the esophageal entrance, close to the laryngopharynx cavity with large operating space, suspension laryngoscopy is the first choice according to the principle of proximity. In all cases, a lateral cleft laryngoscope was used to expose the posterior or lateral wall of the laryngopharynx, and 30° endoscope or microscope was used according to the skills of the surgeon.\n\nFor a foreign body below the esophageal entrance, the lateral cervical incision was the first choice due to the small operating space of oral exposure. The lateral cervical incision and other open surgical methods are used for foreign bodies below the entrance of the esophagus or in the submaxillary space or for the anterior cervical band muscle foreign bodies.', 'armGroupLabels': ['Conventional surgery group', 'New surgery group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong-Gang Duan, doctor', 'role': 'CONTACT', 'email': '2314061@zju.edu.cn', 'phone': '86(China)-571-87783774'}], 'facility': 'Department of Otolaryngology, Second Affiliated Hospital, College of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Hong-Gang Duan, doctor', 'role': 'CONTACT', 'email': '2314061@zju.edu.cn', 'phone': '86(China)-571-87783774'}, {'name': 'Fang Ji, master', 'role': 'CONTACT', 'email': '1506061@zju.edu.cn', 'phone': '86(China)-571-87783774'}], 'overallOfficials': [{'name': 'Hong-Gang Duan, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Affiliated Hospital, College of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-11-24', 'type': 'RELEASE'}, {'date': '2024-05-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}}}}