Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT02852161
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2016-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}, {'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2016-07-28', 'studyFirstSubmitQcDate': '2016-07-28', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuarcy', 'timeFrame': 'immediate', 'description': 'endoscopic'}], 'secondaryOutcomes': [{'measure': 'comfort', 'timeFrame': '2 weeks', 'description': 'questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Barrett's Oesophagus", 'Oesophageal Varices']}, 'referencesModule': {'references': [{'pmid': '31678203', 'type': 'DERIVED', 'citation': "Beg S, Card T, Warburton S, Rahman I, Wilkes E, White J, Ragunath K. Diagnosis of Barrett's esophagus and esophageal varices using a magnetically assisted capsule endoscopy system. Gastrointest Endosc. 2020 Apr;91(4):773-781.e1. doi: 10.1016/j.gie.2019.10.031. Epub 2019 Oct 31."}]}, 'descriptionModule': {'briefSummary': 'A pilot study to assess the accuracy and acceptability of a magnet assisted capsule endoscopy in detecting esophageal pathology compared to standard endoscopy.', 'detailedDescription': 'This will be a single centre feasibility study performed at Nottingham University Hospitals NHS Trusts.\n\nWe will assess the accuracy of MACE compared to gastroscopy in diagnosing Barretts oesophagus and esophageal varices. Patients will have both tests on the same ay, with the endoscopic findings compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nDue to have a clinically indicated gastroscopy Barrett's oesophagus/ oesophageal varices or Controls Able to give informed consent\n\nExclusion Criteria:\n\nUnable to give consent Pregnant Pacemaker swallowing difficulties"}, 'identificationModule': {'nctId': 'NCT02852161', 'acronym': 'MACE', 'briefTitle': 'The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study', 'orgStudyIdInfo': {'id': '15109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MACE', 'description': 'MACE procedure', 'interventionNames': ['Device: Magnet assissted capsule endoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OGD', 'description': 'Clinically indicated gastroscopy', 'interventionNames': ['Device: Magnet assissted capsule endoscopy']}], 'interventions': [{'name': 'Magnet assissted capsule endoscopy', 'type': 'DEVICE', 'description': 'Patients due to have a clinically indicated gastroscopy will be asked to have a MACE procedure on the same day', 'armGroupLabels': ['MACE', 'OGD']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Krish Ragunath', 'role': 'STUDY_CHAIR', 'affiliation': 'Nottingham University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}