Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT01193556
Status:
TERMINATED
Last Update Posted:
2013-01-03
First Post:
2010-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014069', 'term': 'Tonsillitis'}, {'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D010612', 'term': 'Pharyngitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004598', 'term': 'Electrosurgery'}, {'id': 'D004564', 'term': 'Electrocoagulation'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.e.swain@medtronic.com', 'phone': '(+1-603) 294-5428', 'title': 'Robert Swain, PhD', 'organization': 'Medtronic Surgical Technologies'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "Upon Medtronic's acquisition of PEAK surgical, a study integrity audit was undertaken. Results of the audit showed that patient's rights and safety were maintained, but the source data, including baseline demographics, were unverifiable."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care (SOC)', 'description': 'Traditional electrosurgery will be used for the tonsillectomy.', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the tonsillectomy.', 'otherNumAtRisk': 25, 'otherNumAffected': 4, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea/vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Postoperative bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures'}], 'seriousEvents': [{'term': 'Postoperative bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-operative Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Traditional electrosurgery will be used for the tonsillectomy.'}, {'id': 'OG001', 'title': 'PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the tonsillectomy.'}], 'timeFrame': '10 days immediately following surgery', 'description': 'The primary outcome measure will be pain in each treatment group, as measured by visual analog scale twice daily in the 10 day period directly following surgery.', 'reportingStatus': 'POSTED', 'populationDescription': 'An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.'}, {'type': 'SECONDARY', 'title': 'Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Traditional electrosurgery will be used for the tonsillectomy.'}, {'id': 'OG001', 'title': 'PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the tonsillectomy.'}], 'timeFrame': '1-2 weeks post-operatively', 'reportingStatus': 'POSTED', 'populationDescription': 'An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care (SOC)', 'description': 'Traditional electrosurgery will be used for the tonsillectomy.'}, {'id': 'FG001', 'title': 'PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the tonsillectomy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Study termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care (SOC)', 'description': 'Traditional electrosurgery will be used for the tonsillectomy.'}, {'id': 'BG001', 'title': 'PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the tonsillectomy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Children (3-17 years)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Adults (18 years and older)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'partipants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'whyStopped': 'Termination due to acquisition of PEAK Surgical by Medtronic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-29', 'studyFirstSubmitDate': '2010-08-31', 'resultsFirstSubmitDate': '2012-11-29', 'studyFirstSubmitQcDate': '2010-09-01', 'lastUpdatePostDateStruct': {'date': '2013-01-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-29', 'studyFirstPostDateStruct': {'date': '2010-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Pain', 'timeFrame': '10 days immediately following surgery', 'description': 'The primary outcome measure will be pain in each treatment group, as measured by visual analog scale twice daily in the 10 day period directly following surgery.'}], 'secondaryOutcomes': [{'measure': 'Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level', 'timeFrame': '1-2 weeks post-operatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tonsillectomy', 'PlasmaBlade', 'Electrosurgery', 'PEAK Surgical', 'Medtronic Advanced Energy', 'Medtronic'], 'conditions': ['Tonsillitis']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® TnA during subcapsular tonsillectomy; to monitor and record post-operative clinical outcome variables; and to compare these endpoints to the Standard of Care (SOC).', 'detailedDescription': 'Tonsillectomy is performed in response to cases of repeated occurrence of acute tonsillitis or adenoiditis, obstructive sleep apnea, nasal airway obstruction, snoring, or peritonsillar abscess.\n\nThe PEAK PlasmaBlade uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, orthopedic, and ear, nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the post-operative outcome of patients undergoing tonsillectomy.\n\nTwo study sites were granted approval for this prospective randomized study. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were required to provide informed consent for themselves (adults) or for their child prior to enrollment. Following enrollment, subjects were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for tonsillectomy or tonsillectomy and adenoidectomy (TnA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children \\& adolescents: Age 3-17; Adults: 18 and older\n2. Physically healthy, stable weight\n3. Requiring tonsillectomy and adenoidectomy per widely accepted indications\n4. For adults, subject must understand the nature of the procedure and provide written informed consent.\n5. For children and adolescents age 7 to 17, subject must understand the nature of the procedure and be able to give verbal assent prior to the procedure. In addition, parent or guardian must provide written informed consent.\n6. For children under 7 years old, parent or guardian must understand the nature of the procedure and provide written informed consent.\n7. Subject (or responsible parent or guardian) must be willing and able to comply with all follow-up evaluations, including completion of study data sheets.\n\nExclusion Criteria:\n\n1. Children: Age 2 and under\n2. Bleeding disorder\n3. Peritonsillar abscess\n4. Requiring concomitant uvulopalatopharyngoplasty (UPPP)\n5. Anticoagulation therapy which cannot be discontinued\n6. Unable to follow instructions or complete follow-up\n7. Currently taking any medication known to affect healing\n8. Currently enrolled in another investigational device or drug trial'}, 'identificationModule': {'nctId': 'NCT01193556', 'acronym': 'PRECISE', 'briefTitle': 'PEAK PlasmaBlade TnA Versus Traditional Electrosurgery in Subcapsular Tonsillectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Surgical Technologies'}, 'officialTitle': 'A Prospective, Randomized, Double-blinded, Controlled Study to Evaluate Use of the PEAK PlasmaBlade TnA in Subcapsular Tonsillectomy', 'orgStudyIdInfo': {'id': 'PEAK VP-00075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Traditional electrosurgery will be used for the tonsillectomy.', 'interventionNames': ['Device: Traditional Electrosurgery with scalpel']}, {'type': 'EXPERIMENTAL', 'label': 'PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the tonsillectomy.', 'interventionNames': ['Device: PEAK PlasmaBlade TnA']}], 'interventions': [{'name': 'PEAK PlasmaBlade TnA', 'type': 'DEVICE', 'otherNames': ['PEAK', 'PlasmaBlade', 'Plasma Blade', 'TnA', 'Tonsil and Adenoid'], 'description': 'The PEAK PlasmaBlade will be used for the tonsillectomy.', 'armGroupLabels': ['PlasmaBlade']}, {'name': 'Traditional Electrosurgery with scalpel', 'type': 'DEVICE', 'otherNames': ['Electrosurgery', 'Electrocautery', 'Bovie'], 'description': 'Traditional electrosurgery for the tonsillectomy.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95340', 'city': 'Merced', 'state': 'California', 'country': 'United States', 'facility': 'University Surgery Center Merced', 'geoPoint': {'lat': 37.30216, 'lon': -120.48297}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Alvarado Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Brian Weeks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senta Clinic'}, {'name': 'Mark Spitzer, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mark Spitzer, DO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Surgical Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}