Viewing Study NCT00505557



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Study NCT ID: NCT00505557
Status: COMPLETED
Last Update Posted: 2009-06-24
First Post: 2007-07-20

Brief Title: Dual-Plane Breast Augmentation Axillary Approach With Assistant of Endoscope
Sponsor: Chinese Academy of Sciences
Organization: Chinese Academy of Sciences

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2009-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 30endoscope 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None