Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-07 @ 7:08 AM
Study NCT ID:
NCT04320095
Status:
UNKNOWN
Last Update Posted:
2020-03-31
First Post:
2020-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tonsillectomy Using BiZact Tonsilletomy Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2020-03-22', 'studyFirstSubmitQcDate': '2020-03-22', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'during the procedure', 'description': 'The study will be considered success if the mean intra operative time using Bizact device is less than that using electrocautery'}], 'secondaryOutcomes': [{'measure': 'Intraoperative blood loss', 'timeFrame': 'during the procedure', 'description': 'The study will be considered success if the mean intraoperative blood loss using Bizact is less than Electrocautery'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Tonsillectomy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe how Bizact Tonsillectomy Device might affect operative time and intraoperative blood loss in pediatric patients undergoing tonsillectomy, and compare these parameters to the standard technique in tonsillectomy at our institution, which is electrocautery.', 'detailedDescription': 'It is a prospective, interventional, single-center study on the performance of Bizact tonsillectomy device on children undergoing tonsillectomy.The required parameters concerning operative time and intra operative blood loss will be obtained during the procedure.There will be no extra clinical visits for the participants.\n\nOperative time will be assessed in 2 ways: 1). By using blade-tipped electrocautery on one tonsil and the BiZact device on the other tonsil for same patient; and 2). using electrocautery for removal of both tonsils and comparing the operative time to an equal number of cases wherein the BiZact device was used for removal of both tonsils.\n\nWith regard to intra operative bleeding, it will be quantified into one of 3 groups: 1). No blood in suction tubing, 2). blood in suction tubing but not in the suction canister, and 3). blood in the suction canister.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children scheduled for tonsillectomy at Alberta Children Hospital\n2. Tonsillectomy for either recurrent tonsillitis or sleep-disordered breathing.\n\nExclusion Criteria:\n\n1. Craniofacial abnormalities\n2. Bleeding disorders\n3. Complex medical background'}, 'identificationModule': {'nctId': 'NCT04320095', 'briefTitle': 'Tonsillectomy Using BiZact Tonsilletomy Device', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'BiZact Versus Electrocautery in Tonsillectomy: A Single-Center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'REB19-0088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bizact device for one tonsil', 'description': 'Bizact tonsillecotmy device which is an advanced bipolar device using radiofrequency and pressure to ligate the encountered vessels during tonsillectomy.', 'interventionNames': ['Device: Bizact tonsillectomy device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Electrocautery for second tonsil', 'description': 'Electrocautery is the standard technique used at our institution.', 'interventionNames': ['Device: Bizact tonsillectomy device']}, {'type': 'EXPERIMENTAL', 'label': 'Bizact device for both tonsils', 'description': 'Consecutive cases of tonsillectomy will be done using Bizact device and compare the operative time collectively for those cases and compare it to same number of cases done using the standard procedure ( Electrocautery)', 'interventionNames': ['Device: Bizact tonsillectomy device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Electrocautery for both tonsils', 'description': 'As explained on the above arm description', 'interventionNames': ['Device: Bizact tonsillectomy device']}], 'interventions': [{'name': 'Bizact tonsillectomy device', 'type': 'DEVICE', 'description': 'Bizact tonsillectomy device is an advanced bipolar instrument that uses radiofrequency energy and pressure to ligate vessels interposed between its jaws. The energy produced by the device is automatically adjusted based on tissue impedance in an attempt to minimize thermal tissue damage.', 'armGroupLabels': ['Bizact device for both tonsils', 'Bizact device for one tonsil', 'Electrocautery for both tonsils', 'Electrocautery for second tonsil']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Khaloud Al Bahri, MD', 'role': 'CONTACT', 'email': 'khaloud.albahri@ucalgary.ca', 'phone': '587-888-1284'}, {'name': 'Warren Yunker, MD, PhD', 'role': 'CONTACT', 'email': 'Warren.Yunker@albertahealthservices.ca'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}