Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-10 @ 7:31 PM
Study NCT ID:
NCT03902704
Status:
UNKNOWN
Last Update Posted:
2022-05-16
First Post:
2019-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Cleverscope. A New Medical Device for Tracheal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020704', 'term': 'Laryngoscopes'}], 'ancestors': [{'id': 'D019723', 'term': 'Endoscopes'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'part 1 its single group of participants(50 patients without difficult airways predictors). this group receives direct laringoscopy with common laryngoscope (L) during the initial phase of the trial, followed by videolaryngoscope (VL) Cleverscope (used for intubation) during a later phase.\n\npart 2 of the study its two-by-two cross-over assignment involves two groups of participants(84 patients with difficult airways predictors). One group receives VL with C-MAC during the initial phase of the trial, followed by Cleverscope for intubation during a later phase. The other group receives VL with Cleverscope during the initial phase, followed by C-MAC VL used for intubation. So during the part 2 trial, participants "cross over" to the other videolaringoscopy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-13', 'studyFirstSubmitDate': '2019-03-31', 'studyFirstSubmitQcDate': '2019-04-03', 'lastUpdatePostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate)', 'timeFrame': 'intraoperative', 'description': 'degree of glotis visualization'}], 'secondaryOutcomes': [{'measure': 'First attempt intubation success rate', 'timeFrame': 'intraoperative', 'description': 'the rate of traqueal tube pass through vocal cords at first attemps.'}, {'measure': 'overall success intubation rate with same device', 'timeFrame': 'intraoperative', 'description': 'it could include more attempts'}, {'measure': 'time to success', 'timeFrame': 'intraoperative', 'description': 'time wasted from device inserted into mouth to inflate tracheal tube'}, {'measure': 'complications rate', 'timeFrame': 'intraoperative', 'description': 'register complications during intubation or due device usage. like hemorrage, mucosal laceration,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['videolaryngoscopy', 'tracheal intubation'], 'conditions': ['Anesthesia Intubation Complication', 'Difficult Intubation']}, 'descriptionModule': {'briefSummary': 'Cleverscope is a new medical device that transform a laryngoscope into a videolaryngoscope. previous its commercialization we evaluate its safety and efficacy.', 'detailedDescription': 'the investigators develope two part study. part I: the investigators collect data of 50 patients prospectively programed for general anesthesia and tracheal intubation without predictors of difficult airways. this patients were intubated with cleverscope, the investigators register best cormack-lehane (glottic vision) obtained with Cleverscope and best cormack obtained with direct laryngoscopy. the investigators register intubation succes rate and any complications during its use and after extubation.\n\npart II: after confirm safety and efficacy in patients without difficult airways (part I) the investigators use Cleverscope for the same pourpose on difficult airways patients. collecting same data . the investigators compare cormack-lehane in this patients with Cleverscope and commercial Videolaryngoscope C-MAC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* part 1: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation without predictors of difficult intubation :\n\n 1. Arne Test \\< 10\n 2. cervical circunference / tyromental distance \\< 4.\n* part 2: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation with predictors of difficult intubation :\n\n 1. Arne Test \\> 10\n 2. cervical circunference / tyromental distance \\> 4.\n\nExclusion Criteria:\n\n* no mouth openning \\>2cm\n* required use of awake fiberscope por tracheal intubation'}, 'identificationModule': {'nctId': 'NCT03902704', 'briefTitle': 'Safety and Efficacy of Cleverscope. A New Medical Device for Tracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario de Valencia'}, 'officialTitle': 'Safety and Efficacy Assessment of a New Tracheal Intubation Device Cleverscope. Success Rate of Cleverscope in Patients With Suspected Difficult Airway.', 'orgStudyIdInfo': {'id': 'Rov-Clever-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cleverscope', 'description': 'Cleverscope is a new videolaryngoscope used for tracheal intubation. in this group we use this device to intubate participants.', 'interventionNames': ['Device: Cleverscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laryngoscope / Videolaryngoscope C-MAC® Storz', 'description': 'in this group we use a standart comercial device for intubation (laryngoscope or C-MAC) to intubate participants', 'interventionNames': ['Device: Laryngoscope / Videolaryngoscope C-MAC® Storz']}], 'interventions': [{'name': 'Cleverscope', 'type': 'DEVICE', 'description': 'the device is used in patients without difficult airways predictors', 'armGroupLabels': ['Cleverscope']}, {'name': 'Laryngoscope / Videolaryngoscope C-MAC® Storz', 'type': 'DEVICE', 'description': 'the device is used in patients with difficult airways predictors', 'armGroupLabels': ['Laryngoscope / Videolaryngoscope C-MAC® Storz']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46185', 'city': 'La Pobla de Vallbona', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Lucas Rovira, PhD', 'role': 'CONTACT', 'email': 'lucasrovira@gmail.com', 'phone': '+34659276476'}, {'name': 'Lucas Rovira, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lucas Rovira', 'geoPoint': {'lat': 39.59747, 'lon': -0.55468}}], 'centralContacts': [{'name': 'Lucas Rovira, PhD', 'role': 'CONTACT', 'email': 'lucasrovira@gmail.com', 'phone': '+34659276476'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario de Valencia', 'class': 'OTHER'}, 'collaborators': [{'name': 'FIPSE', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lucas Rovira', 'investigatorAffiliation': 'Hospital General Universitario de Valencia'}}}}