Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-31 @ 1:12 AM
Study NCT ID:
NCT03704259
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2018-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nano-Ceramic Coating for Laparoscope Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2018-09-12', 'studyFirstSubmitQcDate': '2018-10-09', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of fogging or smearing (per hour)', 'timeFrame': 'One month', 'description': 'The investigator calculates the number of times the lens is visibly fogged or smeared per hour of operation.'}, {'measure': 'rate of fogging or smearing (per single operation)', 'timeFrame': 'One month', 'description': 'The investigator calculates the number of times the lens is visibly fogged or smeared during a single operation.'}, {'measure': 'rate of extraction for cleaning (per hour)', 'timeFrame': 'One month', 'description': 'The investigator calculates the number of times the lens needs to be extracted from the abdomen for cleaning per hour of operation.'}, {'measure': 'Rate of extraction for cleaning (per operation)', 'timeFrame': 'One month', 'description': 'The investigator calculates the number of times the lens needs to be extracted from the abdomen for cleaning per single operation.'}, {'measure': 'The time consumption for lens cleaning (per hour)', 'timeFrame': 'One month', 'description': 'The investigator calculates the time consumption of the cleaning process as a total (in minutes) per hour.'}, {'measure': 'The time consumption for lens cleaning (per single operation)', 'timeFrame': 'One month', 'description': 'The investigator calculates the time consumption of the cleaning process as a total (in minutes) per single operation.'}, {'measure': 'Cleaning difficulty (per hour)', 'timeFrame': 'One month', 'description': 'The investigator calculates how many times the lens needed more measures for cleaning than simple wiping E.G immersion in hot saline per hour'}, {'measure': 'Cleaning difficulty (per single operation)', 'timeFrame': 'One month', 'description': 'The investigator calculates how many times the lens needed more measures for cleaning than simple wiping E.G immersion in hot saline per hour'}], 'secondaryOutcomes': [{'measure': 'Affecting the lens function', 'timeFrame': 'One month', 'description': "This is a subjective assessment measure, represented by the operators' statement about whether coating the lens affected its vision I.E whether there is a difference in acuity of vision between the coated and the non-coated lens in the absence of any fogging or smearing.\n\nStatement is given as one of five choices:\n\n1. coated lens is notably better (significant difference)\n2. coated lens is slightly better (negligible difference)\n3. non-coated lens is notably better (significant difference)\n4. non-coated lens is slightly better (negligible difference)\n5. no difference"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Laparoscopic Surgical Procedures']}, 'referencesModule': {'references': [{'pmid': '28791559', 'type': 'BACKGROUND', 'citation': "Manning TG, Papa N, Perera M, McGrath S, Christidis D, Khan M, O'Beirne R, Campbell N, Bolton D, Lawrentschuk N. Laparoscopic lens fogging: solving a common surgical problem in standard and robotic laparoscopes via a scientific model. Surg Endosc. 2018 Mar;32(3):1600-1606. doi: 10.1007/s00464-017-5772-x. Epub 2017 Aug 8."}]}, 'descriptionModule': {'briefSummary': 'The investigator tests the effectiveness of nano-ceramic coating when applied (painted) on laparoscope lens to protect it from fogging or smearing during laparoscopic operations', 'detailedDescription': 'A Ceramic Coating is a liquid polymer that is applied by hand to surfaces to make them resistant to scratching, staining, rust or oxidation, as well as "hydrophilic", meaning that water or mud doesn\'t stick to them and so, they become much easier to clean. It was publicly commercialized in recent years for use on automobiles to preserve their gloss, protect their paint, preserve the clarity of their wind shields and headlights so as to provide better lighting and vision.\n\nOn the other hand, lens fogging and other vision-obstructing events during laparoscopic or endoscopic operations(e.g. being smeared by blood or other body fluids during operation, or having a piece of loose tissue stick to its surface that require manual removal and wiping) have been an ever-lasting concern for operators ever since the advent of the respective devices. Many techniques and methods have developed, tested and compared regarding their effectiveness in protecting the lens from such events and preserving vision clear and uninterrupted during operations. Examples of such methods are (scope warmers, FREDTM, ResoclearTM, chlorhexidine, betadine and immersion in heated saline.\n\nIn this study the investigator seeks to apply the idea of nano-ceramic coating as a new technique for achieving that goal. to the investigator\'s best knowledge, this idea was never conceived or tested in the field before.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted for laparoscopic operations', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient requiring laparoscopic operation\n\nExclusion Criteria:\n\n* Any intra-operative event or obstacle that requires conversion to open surgery'}, 'identificationModule': {'nctId': 'NCT03704259', 'briefTitle': 'Nano-Ceramic Coating for Laparoscope Lens', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Nano-Ceramic Coating for Laparoscope Lens: a Cheap Magical Solution for Lens Fogging and Smearing', 'orgStudyIdInfo': {'id': 'ZagazigELSU'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ceramic coating', 'type': 'OTHER', 'otherNames': ['nan-ceramic coating'], 'description': 'coating the laparoscope lens with commercial brand ceramic coating, bought from car service centers specialized in such applications'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44511', 'city': 'Zagazig', 'state': 'Elsharkia', 'country': 'Egypt', 'facility': 'Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Dr., Master's degree, assistant lecturer of general surgery", 'investigatorFullName': 'yousef ahmed el-ayman', 'investigatorAffiliation': 'Zagazig University'}}}}