NCT00505557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

June 24, 2009

Status Verified

June 1, 2009

Enrollment Period

11 months

First QC Date

July 20, 2007

Last Update Submit

June 23, 2009

Conditions

Mammoplasty

Keywords

augmentation mammoplastyDual planeEndoscopeTransaxillary incision

Outcome Measures

Primary Outcomes (1)

  • 98% of the patient satisfied with softer, more natural breasts. The procedure provided more accurate bleeding control, faster postoperative coverage.

    within half year after surgery

Interventions

Transaxillary dual plane techniquePROCEDURE

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All women who want breast augmentation using the implants.Especially for the patients with
  • glandular ptotic (\< I degree) breasts
  • thick soft tissues (\> 10 mm) in the low pole of the breast

You may not qualify if:

  • With thin soft tissues (\< 9 mm) in the low pole of the breast

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plastic Surgery Hospital Affilicated to Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, 100041, China

Location

Related Publications (8)

  • 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: 16733771BACKGROUND

  • 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: 10890950BACKGROUND

  • 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: 10096613BACKGROUND

  • 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: 8826586BACKGROUND

  • 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: 17099485BACKGROUND

  • 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: 17099484BACKGROUND

  • 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: 11743433BACKGROUND

  • 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.

    PMID: 11373572BACKGROUND

Study Officials

  • Yilin Cao, M.D.

    Chinese Academy of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 23, 2007

Study Start

May 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2008

Last Updated

June 24, 2009

Record last verified: 2009-06

Locations

CN(1)