Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT01404351
Status:
WITHDRAWN
Last Update Posted:
2013-01-07
First Post:
2011-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536821', 'term': 'Gigantomastia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study terminated due to the acquisition of PEAK Surgical by Medtronic', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-03', 'studyFirstSubmitDate': '2011-07-25', 'studyFirstSubmitQcDate': '2011-07-27', 'lastUpdatePostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in pain', 'timeFrame': '24 hours and first 10 days post-op', 'description': 'The primary endpoint will be the difference in pain between the Harmonic and PlasmaBlade operative sites. The primary efficacy variable will be pain at each treatment arm operative site, as measured by visual analog scale for 24 hours post-operatively and for 10 post-op days twice daily.'}], 'secondaryOutcomes': [{'measure': 'Operative performance', 'timeFrame': 'Intraoperatively on day 0', 'description': 'Dissection time (normalized), estimated blood loss, use of traditional device for bleeding control, volume of tissue resection.'}, {'measure': 'Adverse events', 'timeFrame': '1 month post-operatively', 'description': 'Monitoring for adverse events following surgery, including hematoma, seroma, wound dehiscence, etc.'}, {'measure': 'Cutaneous scarring', 'timeFrame': 'Up to one year post-operatively', 'description': 'Scar width, quality, pigmentation, elevation, nodularity, thickness, and cosmetic appearance will be blindly evaluated by subject and independent observers.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Reduction mammaplasty', 'Breast reduction', 'PlasmaBlade', 'PEAK'], 'conditions': ['Macromastia (Symptomatic)']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and to compare these outcomes to the HARMONIC SYNERGY® BLADE.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 70\n2. Physically healthy, stable weight\n3. No smoking \\<1 month prior to surgery and during study.\n4. Desiring bilateral breast reduction\n5. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.\n6. Subject must be willing and able to comply with specified follow-up evaluations.\n7. Female subjects must either be incapable of reproduction, or taking acceptable measures to prevent pregnancy and have a negative pregnancy test prior to participation in the study.\n\nExclusion Criteria:\n\n1. Age younger than 18 or greater than 70 years old\n2. Anticoagulation therapy which cannot be discontinued\n3. Smoking \\<1 month prior to surgery or during study\n4. Infection (local or systemic)\n5. Cognitive impairment or mental illness\n6. Severe cardiopulmonary deficiencies\n7. Known coagulopathy\n8. Immunocompromised\n9. Prior history of breast cancer\n10. Kidney disease (any type)\n11. Currently taking any medication known to affect healing\n12. Subjects who are status-post gastric banding or gastric bypass\n13. Currently enrolled in another investigational device or drug trial\n14. Unable to follow instructions or complete follow-up'}, 'identificationModule': {'nctId': 'NCT01404351', 'briefTitle': 'Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Surgical Technologies'}, 'officialTitle': 'A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade® 4.0 in Bilateral Breast Reduction', 'orgStudyIdInfo': {'id': 'VP-00133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEAK PlasmaBlade', 'interventionNames': ['Device: PEAK PlasmaBlade']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'The Standard of Care arm will consist of the scalpel for the skin incision and traditional electrosurgery for subcutaneous dissection.', 'interventionNames': ['Procedure: Scalpel and Traditional Electrosurgery']}], 'interventions': [{'name': 'PEAK PlasmaBlade', 'type': 'DEVICE', 'armGroupLabels': ['PEAK PlasmaBlade']}, {'name': 'Scalpel and Traditional Electrosurgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80534', 'city': 'Johnstown', 'state': 'Colorado', 'country': 'United States', 'facility': 'Gonyon Cosmetic & Plastic Surgery, PC', 'geoPoint': {'lat': 40.33693, 'lon': -104.9122}}], 'overallOfficials': [{'name': 'Denis Gonyon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gonyon Cosmetic & Plastic Surgery, PC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Surgical Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}