Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT04605003
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2020-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The swabbing of the endoscopes are performed by a research assistant, and the end result is evaluated by the primary investigator'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-25', 'studyFirstSubmitDate': '2020-10-16', 'studyFirstSubmitQcDate': '2020-10-25', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbial and Hepatitis B test', 'timeFrame': '3 days', 'description': 'Rigid endoscopes are swabbed and tested using a hep-B kit'}], 'secondaryOutcomes': [{'measure': 'Acidity level', 'timeFrame': '4 hours', 'description': 'Acidity level of the high level disinfectant is tested for every 10 cycles of scope'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sterility']}, 'descriptionModule': {'briefSummary': 'This study compares the sterility of rigid nasoendoscopies after being sterilized with a conventional autoclave machine and a novel rig-S device that uses standard high level disinfectant', 'detailedDescription': 'There is a standard operating procedure in rigid endoscopy cleaning, and it is performed after each clinical examination. The conventional autoclave is no longer used in the setting of an otorhinolaryngology (ORL) clinic as it is cumbersome and takes a lot of time, and also only cleans one endoscope at a time. There is no standardisation or device that has been reported, and cross contamination has been reported previously. The overturn of patients in the ORL clinic is high, and most practitioners chooses high level disinfectant as a method of sterilising the endoscopes. However, there is no proper device to place these disinfectants in, and results in many cases of broken scopes and cross contamination.\n\nThis study compares the sterility of the rigid endoscopes after being sterilised by the high level disinfectant that is placed in a novel rig-S device with the gold standard conventional autoclave.\n\nThe investigators selected all the rigid endoscopes performed in our ORL clinic and randomised them before subjecting them for a swab test for bacterial and fungal, and also used a test kit to test the presence of Hepatitis B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll rigid endoscopes performed in ORL clinic\n\nExclusion Criteria:\n\nFlexible endoscopes performed in ORL clinic'}, 'identificationModule': {'nctId': 'NCT04605003', 'briefTitle': 'Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Kebangsaan Malaysia Medical Centre'}, 'officialTitle': 'Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Novel rig-S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Autoclave', 'description': 'The conventional autoclave is the gold standard of sterilising all medical equipments.', 'interventionNames': ['Device: Novel rig-S', 'Device: Conventional Autoclave machine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Novel rig-S', 'description': 'A novel devise used with the high level disinfectant', 'interventionNames': ['Device: Novel rig-S', 'Device: Conventional Autoclave machine']}], 'interventions': [{'name': 'Novel rig-S', 'type': 'DEVICE', 'description': 'A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed', 'armGroupLabels': ['Conventional Autoclave', 'Novel rig-S']}, {'name': 'Conventional Autoclave machine', 'type': 'DEVICE', 'description': 'The gold standard device to clean all medical instruments', 'armGroupLabels': ['Conventional Autoclave', 'Novel rig-S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Cheras', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Universiti Kebangsaan Malaysia'}], 'overallOfficials': [{'name': 'Salina Husain, MMED', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universiti Kebangsaan Malaysia Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Kebangsaan Malaysia Medical Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Azlina Ab Rani', 'investigatorAffiliation': 'Universiti Kebangsaan Malaysia Medical Centre'}}}}