Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-22 @ 1:30 PM
Study NCT ID:
NCT02036567
Status:
COMPLETED
Last Update Posted:
2018-09-06
First Post:
2014-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Pain Measurement Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2014-01-13', 'lastUpdatePostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation between pain as measured by the device and reported pain and clinical events, respectively', 'timeFrame': 'average 4 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This longitudinal observational study will attempt to objectively measure pain with an experimental, non-invasive device. Patients and volunteers will receive a baseline screening with psychophysical tests and questionnaires. Investigators will apply the device to measure pain during routine clinical care and correlate patients pain ratings and analgesia requirements to that measured by the device. A more standardized approach with experimental pain stimuli will be pursued in human volunteer studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women of all ethnicities will be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-100 years\n\nExclusion Criteria:\n\n* inability to sign consent'}, 'identificationModule': {'nctId': 'NCT02036567', 'briefTitle': 'Evaluation of Pain Measurement Device', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Longitudinal Observational Pilot Study to Assess the Capabilities of an Experimental Device to Objectively Measure Pain.', 'orgStudyIdInfo': {'id': '28503'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'surgical patients', 'description': 'no interventions, observational study'}, {'label': 'laboring women', 'description': 'no interventions, observational study'}, {'label': 'volunteers', 'description': 'pain induction by noxious heat stimulation, measurement of pain by device and documentation of pain reported by subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Department of Anesthesia, Pain and Perioperative Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Alexander Z Tzabazis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Alexander Zacharias Tzabazis', 'investigatorAffiliation': 'Stanford University'}}}}