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Tracking Information | |||||
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First Received Date † | July 20, 2007 | ||||
Last Updated Date | July 23, 2007 | ||||
Start Date † | May 2006 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00505557 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Dual-Plane Breast Augmentation: Axillary Approach With Assistant of Endoscope | ||||
Official Title † | |||||
Brief Summary | 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. |
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Detailed Description | 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. The endoscope assistant technique has been widely used in transaxillary breast augmentation. It provides the feasibility to perform dual plane breast augmentation by axillary approach. In 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. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Single Blind, Parallel Assignment | ||||
Condition † | Mammoplasty | ||||
Intervention † | Procedure: Transaxillary dual plane technique | ||||
Study Arms / Comparison Groups | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | |||||
Completion Date | July 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years to 40 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | China | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00505557 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Chinese Academy of Sciences | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Chinese Academy of Sciences | ||||
Verification Date | July 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |