Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-31 @ 10:01 AM
Study NCT ID:
NCT05044104
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2021-09-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Wearable Technology in Endoscopy
Sponsor:
Organization:
Raw JSON
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as part of standard of care who wore a consumer-facing wearable smart watch for the duration of the procedure.', 'otherNumAtRisk': 292, 'deathsNumAtRisk': 292, 'otherNumAffected': 0, 'seriousNumAtRisk': 292, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recorded Tachycardia Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Undergoing Gastrointestinal Endoscopy With Sedation', 'description': 'Patients who underwent an endoscopic gastrointestinal procedure with sedation as part of standard of care who wore a consumer-facing wearable smart watch for the duration of the procedure.'}], 'classes': [{'title': 'Anesthesia Monitoring', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Smartwatch', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Smartwatch Accessories', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Anesthesia Duration, approximately 30 to 45 minutes', 'description': 'Number of tachycardia events recorded as defined as heart rate \\> 100 bpm', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Recorded Bradycardia Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Undergoing Gastrointestinal Endoscopy With Sedation', 'description': 'Patients who underwent an endoscopic gastrointestinal procedure with sedation as part of standard of care who wore a consumer-facing wearable smart watch for the duration of the procedure.'}], 'classes': [{'title': 'Anesthesia Monitoring', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'Smartwatch', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Accessories', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Anesthesia Duration, approximately 30 to 45 minutes', 'description': 'Number of bradycardia events recorded as defined as heart rate \\< 60 bpm', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Recorded Desaturation Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Undergoing Gastrointestinal Endoscopy With Sedation', 'description': 'Patients who underwent an endoscopic gastrointestinal procedure with sedation as part of standard of care who wore a consumer-facing wearable smart watch for the duration of the procedure.'}], 'classes': [{'title': 'Anesthesia Monitoring', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'Smartwatch', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Smartwatch Accessories', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Anesthesia Duration, approximately 30 to 45 minutes', 'description': 'Number of desaturation events recorded as defined as peripheral O2 saturation \\<88%', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Recorded Arrhythmia Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Undergoing Gastrointestinal Endoscopy With Sedation', 'description': 'Patients who underwent an endoscopic gastrointestinal procedure with sedation as part of standard of care who wore a consumer-facing wearable smart watch for the duration of the procedure.'}], 'classes': [{'title': 'Anesthesia Monitoring', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Smartwatch', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Smartwatch accessories', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Anesthesia Duration, approximately 30 to 45 minutes', 'description': 'Number of arrhythmia events recorded', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Recorded Tachypnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Undergoing Gastrointestinal Endoscopy With Sedation', 'description': 'Patients who underwent an endoscopic gastrointestinal procedure with sedation as part of standard of care who wore a consumer-facing wearable smart watch for the duration of the procedure.'}], 'classes': [{'title': 'Anesthesia Monitoring', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Smartwatch', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Smartwatch accessories', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Anesthesia Duration, approximately 30 to 45 minutes', 'description': 'Number of tachypnea events recorded as defined as respiratory rate \\>18 breaths per minute', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Undergoing Gastrointestinal Endoscopy With Sedation', 'description': 'Patients who underwent an endoscopic gastrointestinal procedure with sedation as part of standard of care who wore a consumer-facing wearable smart watch for the duration of the procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Undergoing Gastrointestinal Endoscopy With Sedation', 'description': 'Patients who underwent an endoscopic gastrointestinal procedure with sedation as part of standard of care who wore a consumer-facing wearable smart watch for the duration of the procedure.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'BG000', 'lowerLimit': '45.8', 'upperLimit': '71.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '173', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '119', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-04', 'size': 443767, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-15T09:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-14', 'studyFirstSubmitDate': '2021-09-04', 'resultsFirstSubmitDate': '2023-06-16', 'studyFirstSubmitQcDate': '2021-09-04', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-14', 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recorded Tachycardia Events', 'timeFrame': 'Anesthesia Duration, approximately 30 to 45 minutes', 'description': 'Number of tachycardia events recorded as defined as heart rate \\> 100 bpm'}, {'measure': 'Recorded Bradycardia Events', 'timeFrame': 'Anesthesia Duration, approximately 30 to 45 minutes', 'description': 'Number of bradycardia events recorded as defined as heart rate \\< 60 bpm'}, {'measure': 'Recorded Desaturation Events', 'timeFrame': 'Anesthesia Duration, approximately 30 to 45 minutes', 'description': 'Number of desaturation events recorded as defined as peripheral O2 saturation \\<88%'}, {'measure': 'Recorded Arrhythmia Events', 'timeFrame': 'Anesthesia Duration, approximately 30 to 45 minutes', 'description': 'Number of arrhythmia events recorded'}, {'measure': 'Recorded Tachypnea', 'timeFrame': 'Anesthesia Duration, approximately 30 to 45 minutes', 'description': 'Number of tachypnea events recorded as defined as respiratory rate \\>18 breaths per minute'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Gastrointestinal Endoscopic Procedure with sedation'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are assessing the accuracy and safety of wearable technology in subjects undergoing endoscopic gastrointestinal procedures with sedation.', 'detailedDescription': 'This is a prospective, non-blinded, exploratory study to assess the accuracy and safety of wearable devices in the endoscopy suite with patients undergoing procedures using anesthesia assisted sedation using smart watches. We will also simultaneously perform an assessment of patient and provider preferences using narrative-driven, qualitative evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over 18 years of age.\n* Undergoing anesthesia-assisted endoscopic procedures.\n* Able to give appropriate consent to the study or have an appropriate representative to do so.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Physical deformity, wound, or dressing preventing placement of a wearable device on the wrist.\n* Allergy to aluminum, nickel or acrylate.'}, 'identificationModule': {'nctId': 'NCT05044104', 'briefTitle': 'Wearable Technology in Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Prospective Study of the Role and Accuracy of Consumer-Facing Wearable Technology in Gastrointestinal Endoscopy', 'orgStudyIdInfo': {'id': '21-007738'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wearable technology in endoscopic gastrointestinal procedures with sedation', 'description': 'Subjects undergoing a endoscopic gastrointestinal procedure with sedation as part of standard of care will wear a consumer-facing wearable smart watch for the duration of the procedure.', 'interventionNames': ['Device: Consumer-facing wearable smart watch']}], 'interventions': [{'name': 'Consumer-facing wearable smart watch', 'type': 'DEVICE', 'otherNames': ['Apple Watch Series 6', 'FitBit Versa'], 'description': 'Wearable watch technology that has the ability to measure heart rate, respiratory rate, single-lead electrocardiography, and blood oxygen saturation.', 'armGroupLabels': ['Wearable technology in endoscopic gastrointestinal procedures with sedation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Vinay Chandrasekhara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vinay Chandrasekhara', 'investigatorAffiliation': 'Mayo Clinic'}}}}