Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT03967405
Status:
UNKNOWN
Last Update Posted:
2020-03-06
First Post:
2019-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Evaluation of Clinical Equivalence Between iX and PID
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2019-05-27', 'studyFirstSubmitQcDate': '2019-05-27', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bacterial Load quantification by sampling', 'timeFrame': '2 months', 'description': 'Quantify difference in bacterial load reported by sampling using standard Levine technique (swabbing) compared to FL image-guided curettage scraping.'}], 'primaryOutcomes': [{'measure': 'Concordance', 'timeFrame': '2 months', 'description': 'The inter-reader concordance of the iX and PID FL-images together is not less than the inter-reader concordance of the iX FL-images alone.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and Specificity', 'timeFrame': '2 months', 'description': 'Sensitivity and specificity for detection of moderate/heavy bacterial load of PID FL-images to be equal to or greater than that of i:X FL-images when validated by microbiology gold truth'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Wound', 'Imaging'], 'conditions': ['Wound']}, 'descriptionModule': {'briefSummary': 'Patients with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, a standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.', 'detailedDescription': 'Patients (n = 50) with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic wounds', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) of unknown infection status\n2. 18 years of age or older\n\nExclusion Criteria:\n\n1. Treatment with an investigational drug within 1 month before study enrollment\n2. Subjects with recent (\\<30 days) biopsy or curettage of target wound\n3. Subjects with wounds that cannot be completely imaged by study device due to anatomic location\n4. Unable or unwilling to consent'}, 'identificationModule': {'nctId': 'NCT03967405', 'briefTitle': 'A Prospective Evaluation of Clinical Equivalence Between iX and PID', 'organization': {'class': 'INDUSTRY', 'fullName': 'MolecuLight Inc.'}, 'officialTitle': 'A Prospective Evaluation of Clinical Equivalence Between i:X and PID', 'orgStudyIdInfo': {'id': '19-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MolecuLight PID', 'type': 'DEVICE', 'description': 'Hand-held, real-time fluorescence imaging device'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M2R 1N5', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Judy Dan Research and Treatment Center'}], 'overallOfficials': [{'name': 'Ronald Linden', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Judy Dan Research and Treatment Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to disseminate information to patients. If patients ask for their information then they will be provided a response with the most up to date information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MolecuLight Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}