Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-01-08 @ 3:02 PM
Study NCT ID:
NCT01946633
Status:
UNKNOWN
Last Update Posted:
2013-10-30
First Post:
2013-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote-controlled Capsule Endoscopy: a Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013276', 'term': 'Stomach Ulcer'}, {'id': 'C562464', 'term': 'Polyposis, Gastric'}], 'ancestors': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-28', 'studyFirstSubmitDate': '2013-09-12', 'studyFirstSubmitQcDate': '2013-09-16', 'lastUpdatePostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the percentage of complete visualization of anatomic landmarks', 'timeFrame': '2 year', 'description': 'the percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus'}, {'measure': 'examination time and the percentage of abnormal finding', 'timeFrame': '2 year', 'description': 'examination time and the percentage of abnormal findings seen on gastroscopy that were reproducible by capsule endoscopy'}], 'secondaryOutcomes': [{'measure': 'adverse effect', 'timeFrame': '2 year', 'description': 'any discomfort like chest pain, nausea will be documented. capsule retention（defined as not extrusion in 14 days）will be documented.'}, {'measure': 'Acceptability', 'timeFrame': '2 year', 'description': 'Acceptability to patients was assessed by means of a questionnaire, with ratings on a scale of 0 to 10 and examination chosen for next time. completed in the recovery room immediately after capsule examination.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastric Ulcer', 'Gastric Polyp']}, 'referencesModule': {'references': [{'pmid': '21067740', 'type': 'BACKGROUND', 'citation': 'Keller J, Fibbe C, Volke F, Gerber J, Mosse AC, Reimann-Zawadzki M, Rabinovitz E, Layer P, Schmitt D, Andresen V, Rosien U, Swain P. Inspection of the human stomach using remote-controlled capsule endoscopy: a feasibility study in healthy volunteers (with videos). Gastrointest Endosc. 2011 Jan;73(1):22-8. doi: 10.1016/j.gie.2010.08.053. Epub 2010 Nov 9.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/21067740', 'label': 'Inspection of the human stomach using remote-controlled capsule endoscopy: a feasibility study in healthy volunteers'}]}, 'descriptionModule': {'briefSummary': 'The present study is a feasibility study to assess the safety and efficacy of wireless capsule endoscope and compare the data obtained with those obtained by using a conventional esophagogastroduodenoscopy.\n\nThe product was developed and manufacture in China.(the NaviCam. AKC-1.China)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* upper abdominal symptoms (≥1 year )\n* surveillance gastroscopy for known gastric ulcer or polyps\n* history of gastric ulcer or polyps （≤1w）at Nanfang Hospital were enrolled.\n\nExclusion Criteria:\n\n* dysphagia\n* suspected or documented digestive tract malformation ,obstruction, strictures or fistula\n* acute upper GI bleeding, acute enteritis, acute ischemia disease\n* history of abdominal operations\n* impaired renal function, congestive heart failure\n* patients with critical condition or mental illness\n* patients with, known allergy to polymer material or antifoam agent\n* patients with cardiac pacemakers or other implanted electromedical devices，magnetic resonance imaging ( mri) examination in 7 days\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01946633', 'briefTitle': 'Remote-controlled Capsule Endoscopy: a Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Remote-controlled Capsule Endoscopy: a Feasibility Study', 'orgStudyIdInfo': {'id': 'GNF-NaviCam-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esophagogastroduodenoscopy（ECG）', 'description': 'n=15', 'interventionNames': ['Device: magnetic-controlled capsule endoscopy(Navicam)']}], 'interventions': [{'name': 'magnetic-controlled capsule endoscopy(Navicam)', 'type': 'DEVICE', 'armGroupLabels': ['Esophagogastroduodenoscopy（ECG）']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinying Wang, Associate Professor', 'role': 'CONTACT', 'email': 'sunwingwxy@163.com', 'phone': '86-020-61541540'}], 'facility': 'Departement of Gastroenterology, Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'xinying Wang, Associate Professor', 'role': 'CONTACT', 'email': 'sunwingwxy@163.com', 'phone': '86-020-61541540'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'xinying wang', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}