Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:42 PM
Study NCT ID:
NCT07395193
Status:
COMPLETED
Last Update Posted:
2026-02-10
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of BiZact™, Coblation, and Bipolar Tonsillectomy Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-08', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain (Visual Analog Scale score)', 'timeFrame': 'Postoperative days 1, 3, and 7', 'description': 'Postoperative pain was assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent greater pain intensity.'}, {'measure': 'Surgery time', 'timeFrame': 'During surgery'}], 'secondaryOutcomes': [{'measure': 'Time to first solid food intake', 'timeFrame': 'Within the first postoperative week'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Postoperative Day 1', 'description': 'Duration of hospitalization measured in days following tonsillectomy.'}, {'measure': 'Postoperative bleeding', 'timeFrame': 'Up to 30 days postoperatively'}, {'measure': 'Device cost per case', 'timeFrame': 'Perioperative period (day of surgery)', 'description': 'Cost of the surgical device used for tonsillectomy, calculated per patient.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tonsillectomy'], 'conditions': ['Tonsil Disease', 'Tonsil Disorder']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Bulut O, et al. Comparative Evaluation of BiZact™, Coblation, and Bipolar Tonsillectomy Techniques. Unpublished data.'}]}, 'descriptionModule': {'briefSummary': 'This prospective, non-randomized observational study compared the surgical outcomes of BiZact™, Coblation, and Bipolar tonsillectomy techniques in pediatric and adult patients. Operative efficiency, postoperative pain, recovery parameters, postoperative bleeding, and device-related costs were evaluated.', 'detailedDescription': 'Tonsillectomy is a commonly performed surgical procedure in otorhinolaryngology, and various techniques have been developed to improve operative efficiency and postoperative recovery. This prospective, non-randomized observational study included 150 patients aged 5-40 years who underwent tonsillectomy between November 2024 and September 2025. Patients were allocated to Bipolar, Coblation, or BiZact tonsillectomy groups based on surgeon preference and device availability.\n\nPrimary outcome measures were operative time and postoperative pain assessed using the visual analogue scale on postoperative days 1, 3, and 7. Secondary outcomes included time to first solid food intake, length of hospital stay, postoperative bleeding, bleeding management, and device-related cost. The study aimed to compare clinical outcomes, recovery profiles, and procedural efficiency among the three tonsillectomy techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric and adult patients undergoing tonsillectomy at a tertiary care center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 5 and 40 years\n* Undergoing tonsillectomy\n* Indication for surgery due to recurrent tonsillitis or obstructive sleep-related symptoms\n\nExclusion Criteria:\n\n* Known coagulation disorders\n* Presence of peritonsillar abscess\n* Presence of craniofacial syndromes\n* Incomplete follow-up data'}, 'identificationModule': {'nctId': 'NCT07395193', 'acronym': 'BCB-Tonsillect', 'briefTitle': 'Comparative Evaluation of BiZact™, Coblation, and Bipolar Tonsillectomy Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Medicana Bursa Hospital'}, 'officialTitle': 'A Prospective Observational Study Comparing BiZact™, Coblation, and Bipolar Tonsillectomy Techniques', 'orgStudyIdInfo': {'id': '2024/2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BiZact Tonsillectomy', 'description': 'Patients undergoing tonsillectomy using the BiZact™ device.'}, {'label': 'Coblation Tonsillectomy', 'description': 'Patients undergoing tonsillectomy using the coblation technique.'}, {'label': 'Bipolar Tonsillectomy', 'description': 'Patients undergoing tonsillectomy using bipolar electrocautery.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nilufer', 'state': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Medicana Bursa Hospital', 'geoPoint': {'lat': 40.21401, 'lon': 28.91567}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicana Bursa Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Oktay Bulut', 'investigatorAffiliation': 'Medicana Bursa Hospital'}}}}