Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT04605302
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2020-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-05-23', 'mcpReleaseN': 4, 'releaseDate': '2024-04-29'}, {'resetDate': '2024-12-12', 'mcpReleaseN': 5, 'releaseDate': '2024-11-17'}, {'resetDate': '2025-02-25', 'mcpReleaseN': 6, 'releaseDate': '2025-02-06'}, {'resetDate': '2025-03-19', 'mcpReleaseN': 7, 'releaseDate': '2025-03-01'}], 'estimatedResultsFirstSubmitDate': '2024-04-29'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Patient blinded to MCC results. EGD assessor blinded to MCC results.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Tandem study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2020-10-27', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of lesions', 'timeFrame': '2 days', 'description': 'Number of lesions found by MCC/MCC-T versus EGD'}, {'measure': 'Number of adverse events', 'timeFrame': '2 days', 'description': 'Occurrence and severity of adverse event related to MCC/MCC-T procedure versus EGD procedure'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction score', 'timeFrame': '2 days', 'description': 'Patient acceptance of MCC/MCC-T versus EGD (scale of 1 to 10 when 1 is the lowest and 10 is the highest score)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Upper Gastrointestinal Symptoms']}, 'descriptionModule': {'briefSummary': 'A prospective single blinded, tandem study, comparing a magnetically controlled capsule with or without a tether (MCC or MCC-T) with conventional upper endoscopy for the diagnosis of patients with upper abdominal symptoms.', 'detailedDescription': 'In the US patients commonly undergo esophagogastroduodenoscopy (EGD) for upper abdominal symptoms to try to resolve whether they have gastroesophageal reflux disease or functional dyspepsia, if they are older than the age of 60 with symptoms, or have alarm symptoms such as unexplained weight loss, persistent nausea and vomiting or if they have symptoms that are refractory to acid suppression therapy. Given the increasing burden of digestive disease in the US, the use of EGD is increasing in volume nationwide. EGD usually requires either conscious sedation or monitored anesthesia sedation, which has put an additional cost burden on the healthcare system. Since MCC or MCC-T does not require sedation, it offers an attractive option for both patients and clinicians alike.\n\nThe aim of this study is to compare in the same patient the accuracy of the MCC and MCC-T and EGD in patients presenting with upper abdominal symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is able to provide informed consent\n2. Patient has appropriate indications for EGD including symptoms of, but not limited to upper abdominal pain, acid reflux, heartburn, iron deficiency anemia, weight loss, bloating, belching, nausea, vomiting and atypical chest pain.\n\nExclusion Criteria:\n\n1. Patient with dysphagia.\n2. Patient with previous intestinal surgery.\n3. Patient with Crohn's disease or other potential obstructive conditions, unless there is a recent CTE, MRE or patency capsule performed to exclude an obstructive lesion that may retain the capsule.\n4. Female patient who is pregnant.\n5. Patient with implanted medical device that would be potentially affected by magnets or radiofrequency emissions (e.g., pacemakers, implanted cardiac defibrillators)."}, 'identificationModule': {'nctId': 'NCT04605302', 'briefTitle': 'Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'AnX Robotica Corp.'}, 'officialTitle': 'A Prospective Single Blinded, Pilot Study, Comparing a Magnetically Controlled Capsule With or Without a Tether (MCC or MCC-T) With Conventional Upper Endoscopy for the Diagnosis of Patients With Upper Abdominal Symptoms', 'orgStudyIdInfo': {'id': 'UMASS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm Tandem Study', 'description': 'Patients are assigned to swallow a magnetically controlled capsule first then undergo standard gastroscopy', 'interventionNames': ['Device: MCC/MCC-T', 'Device: Standard gastroscopy']}], 'interventions': [{'name': 'MCC/MCC-T', 'type': 'DEVICE', 'otherNames': ['Magnetic controlled capsule endoscopy with/without tether'], 'description': 'Magnetically controlled capsule endoscopy (MCC), with or without tether, is used to visualize the upper gastrointestinal tract', 'armGroupLabels': ['Single Arm Tandem Study']}, {'name': 'Standard gastroscopy', 'type': 'DEVICE', 'otherNames': ['EGD'], 'description': 'Diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum', 'armGroupLabels': ['Single Arm Tandem Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'David R Cave, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AnX Robotica Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}