Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT03540004
Status:
UNKNOWN
Last Update Posted:
2020-03-06
First Post:
2018-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Soft tissue core biopsies will be obtained from patients with wounds.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 367}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-05-25', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of identifying wounds with moderate/heavy bacterial load as measured by sensitivity and specificity.', 'timeFrame': '1 year', 'description': 'Superiority in sensitivity of clinical signs and symptoms (CSS) and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone to identify wounds with moderate/heavy bacterial load\n\nNon-Inferiority of specificity of CSS and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone with region of indifference of 10% to identify wounds with moderate/heavy bacterial load'}], 'secondaryOutcomes': [{'measure': 'Estimation of sensitivity and specificity of MolecuLight i:X alone', 'timeFrame': '1.5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Wound']}, 'referencesModule': {'references': [{'pmid': '37039975', 'type': 'DERIVED', 'citation': 'Johnson J, Johnson AR Jr, Andersen CA, Kelso MR, Oropallo AR, Serena TE. Skin Pigmentation Impacts the Clinical Diagnosis of Wound Infection: Imaging of Bacterial Burden to Overcome Diagnostic Limitations. J Racial Ethn Health Disparities. 2024 Apr;11(2):1045-1055. doi: 10.1007/s40615-023-01584-8. Epub 2023 Apr 11.'}, {'pmid': '34714159', 'type': 'DERIVED', 'citation': 'Serena TE, Gould L, Ousey K, Kirsner RS. Reliance on Clinical Signs and Symptoms Assessment Leads to Misuse of Antimicrobials: Post hoc Analysis of 350 Chronic Wounds. Adv Wound Care (New Rochelle). 2022 Dec;11(12):639-649. doi: 10.1089/wound.2021.0146. Epub 2021 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'This is a non-randomized evaluation for which 160 adult patients will be imaged at outpatient wound care clinics who present with a wound of unknown infection diagnostic status and are receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an adjunctive tool in the assessment of the wound and may be used to guide the targeted sampling of a wound (using a conventional punch biopsy method).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI)\n* 18 years or older\n\nExclusion Criteria:\n\n* Treatment with an investigational drug within 1 month before study enrolment\n* Subjects with recent (\\<30 days) biopsy of target wound\n* Subjects with wounds that cannot be completely imaged by study device due to anatomic location\n* Inability to consent\n* Any contra-indication to routine wound care and/or monitoring'}, 'identificationModule': {'nctId': 'NCT03540004', 'briefTitle': 'Evaluation of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds', 'organization': {'class': 'INDUSTRY', 'fullName': 'MolecuLight Inc.'}, 'officialTitle': 'A Prospective, Single-blind, Multi-center Clinical Study Evaluating the Use of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds.', 'orgStudyIdInfo': {'id': '18-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MolecuLight i:X Imaging Device', 'type': 'DEVICE', 'description': 'The i:X Imaging Device uses built-in light-emitting diodes (LEDs) emitting 405 nm violet excitation light to illuminate the wound during fluorescence imaging in (FL-Mode). The light excites biological components of the wound and surrounding tissues. Non-biological components may also fluoresce although their presence in wounds is less common, provided the wound has been cleaned following standard care protocols. The resulting wound fluorescence wavelengths emitted are typically between 420 - 700 nm in the visible wavelength spectrum. In FL-mode, a customized fluorescence emission filter, which is mechanically placed in front of the built in imaging sensor and allows real-time capture of wound, limits the visualization of fluorescence to wavelengths between 500-545 nm, which typically appears green in color, and 600-665 nm, which typically appears red in color.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90063', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'New Hope Podiatry Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33027', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Royal Research Group', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '30306', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': "Saint Mary's Center for Wound Healing", 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '70570', 'city': 'Opelousas', 'state': 'Louisiana', 'country': 'United States', 'facility': 'The Wound Treatment Center at Opelousas General Health System', 'geoPoint': {'lat': 30.53353, 'lon': -92.08151}}, {'zip': '44103', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Foot and Ankle Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'The Heal Clinic', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '19010', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Foot and Ankle Center', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}, {'zip': '16544', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Saint Vincent Health Center', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '16226', 'city': 'Ford City', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Foot and Ankle Wellness Center of Western Pennsylvania', 'geoPoint': {'lat': 40.77229, 'lon': -79.52977}}, {'zip': '16201', 'city': 'Kittanning', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Armstrong County Memorial Hospital', 'geoPoint': {'lat': 40.81645, 'lon': -79.52199}}, {'zip': '15222', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Serena Group Research Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '17402', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Martin Foot and Ankle', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}, {'zip': '77437', 'city': 'El Campo', 'state': 'Texas', 'country': 'United States', 'facility': 'El Campo Memorial Hospital', 'geoPoint': {'lat': 29.19664, 'lon': -96.26969}}, {'zip': '77036', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Gulf Coast Medical Group', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Tomas E Serena, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Serena Group Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MolecuLight Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'SerenaGroup, Inc.', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}