Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-26 @ 8:10 PM
Study NCT ID:
NCT00505557
Status:
COMPLETED
Last Update Posted:
2009-06-24
First Post:
2007-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual-Plane Breast Augmentation: Axillary Approach With Assistant of Endoscope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-23', 'studyFirstSubmitDate': '2007-07-20', 'studyFirstSubmitQcDate': '2007-07-20', 'lastUpdatePostDateStruct': {'date': '2009-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '98% of the patient satisfied with softer, more natural breasts. The procedure provided more accurate bleeding control, faster postoperative coverage.', 'timeFrame': 'within half year after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['augmentation mammoplasty', 'Dual plane', 'Endoscope', 'Transaxillary incision'], 'conditions': ['Mammoplasty']}, 'referencesModule': {'references': [{'pmid': '16733771', 'type': 'BACKGROUND', 'citation': 'Yu L, Wang J, Zhang B, Zhu C. Endoscopic transaxillary capsulectomy. Aesthetic Plast Surg. 2006 May-Jun;30(3):282-5. doi: 10.1007/s00266-005-0159-0.'}, {'pmid': '10890950', 'type': 'BACKGROUND', 'citation': 'Villafane O, Garcia-Tutor E, Taggart I. Endoscopic transaxillary subglandular breast augmentation using silicone gel textured implants. Aesthetic Plast Surg. 2000 May-Jun;24(3):212-5. doi: 10.1007/s002660010035.'}, {'pmid': '10096613', 'type': 'BACKGROUND', 'citation': 'Howard PS. The role of endoscopy and implant texture in transaxillary submuscular breast augmentation. Ann Plast Surg. 1999 Mar;42(3):245-8. doi: 10.1097/00000637-199903000-00003.'}, {'pmid': '8826586', 'type': 'BACKGROUND', 'citation': 'Howard PS, Oslin BD, Moore JR. Endoscopic transaxillary submuscular augmentation mammaplasty with textured saline breast implants. Ann Plast Surg. 1996 Jul;37(1):12-7. doi: 10.1097/00000637-199607000-00002.'}, {'pmid': '17099485', 'type': 'BACKGROUND', 'citation': 'Tebbetts JB. Dual plane breast augmentation: optimizing implant-soft-tissue relationships in a wide range of breast types. Plast Reconstr Surg. 2006 Dec;118(7 Suppl):81S-98S; discussion 99S-102S. doi: 10.1097/00006534-200612001-00012.'}, {'pmid': '17099484', 'type': 'BACKGROUND', 'citation': 'Tebbetts JB. Axillary endoscopic breast augmentation: processes derived from a 28-year experience to optimize outcomes. Plast Reconstr Surg. 2006 Dec;118(7 Suppl):53S-80S. doi: 10.1097/01.prs.0000247314.92351.99.'}, {'pmid': '11743433', 'type': 'BACKGROUND', 'citation': 'Tofield JJ. Dual plane breast augmentation. Plast Reconstr Surg. 2001 Dec;108(7):2162-4. doi: 10.1097/00006534-200112000-00069. No abstract available.'}, {'pmid': '11373572', 'type': 'BACKGROUND', 'citation': 'Tebbetts JB. Dual plane breast augmentation: optimizing implant-soft-tissue relationships in a wide range of breast types. Plast Reconstr Surg. 2001 Apr 15;107(5):1255-72. doi: 10.1097/00006534-200104150-00027.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the feasibility and outcome of performing dual plane breast augmentation with assistant of endoscope by axillary approach.', 'detailedDescription': 'Dual plane augmentation mammoplasty is a logical approach to realize the benefits of retromammary and partial retropectoral implant placement while minimizing the tradeoffs of other pocket locations. Traditionally, dual plane augmentation has been performed using transareolar or inframammary fold approach. However, the approach is unacceptable to Chinese patients because of the front scar formation. For aesthetic reasons, the axillary incision is more acceptable approach for augmentation mammoplasty.\n\nThe endoscope assistant technique has been widely used in transaxillary breast augmentation. It provides the feasibility to perform dual plane breast augmentation by axillary approach.\n\nIn this research, at least 40 patients with light degree of glandular ptotic and constricted lower pole breasts are selected to receive soft cohesive gel microtextured anatomic style silicone implants. Portions of the pectoralis major muscle is split without its release from the costal margin with the help of a 10mm, 30°endoscope and endoscopic diathermy scissors through a 4-cm incision in the axilla each side. Bleeding during surgery is kept to the minimum. The results of outcomes, operative time, bleeding volume, drainage volume, complications are observed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women who want breast augmentation using the implants.Especially for the patients with\n* glandular ptotic (\\< I degree) breasts\n* thick soft tissues (\\> 10 mm) in the low pole of the breast\n\nExclusion Criteria:\n\n* With thin soft tissues (\\< 9 mm) in the low pole of the breast'}, 'identificationModule': {'nctId': 'NCT00505557', 'briefTitle': 'Dual-Plane Breast Augmentation: Axillary Approach With Assistant of Endoscope', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Chinese Academy of Sciences'}, 'orgStudyIdInfo': {'id': '621125-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transaxillary dual plane technique', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100041', 'city': 'Beijing', 'country': 'China', 'facility': 'Plastic Surgery Hospital Affilicated to Chinese Academy of Medical Sciences & Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yilin Cao, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Sciences', 'class': 'OTHER_GOV'}}}}