MammoplastyPhase 1NCT00505557
Dual-Plane Breast Augmentation: Axillary Approach With Assistant of Endoscope
A Phase 1 study testing Transaxillary dual plane technique in people with Mammoplasty, run by Chinese Academy of Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Mammoplasty
- What is being tested?
- Transaxillary dual plane technique
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- May 2006to Apr 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- With thin soft tissues (< 9 mm) in the low pole of the breast
Trial locations and contacts
1 site in 1 country.
China1 site
Plastic Surgery Hospital Affilicated to Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, 100041
About this study
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.
Read the 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.
- Conditions
- Mammoplasty
- Being tested
- Transaxillary dual plane technique
- Keywords
- augmentation mammoplasty, Dual plane, Endoscope, Transaxillary incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transaxillary dual plane techniqueProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
98% of the patient satisfied with softer, more natural breasts. The procedure provided more accurate bleeding control, faster postoperative coverage.
Measured: within half year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startMay 2006
- Primary completionApr 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MammoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Investigators
- Yilin Cao, M.D., Study chair, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505557
- Sponsor's protocol ID
- 621125-1
- Status last verified
- Jun 2009
- First submitted
- 20 Jul 2007
- Last updated
- 24 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16733771Villafane 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.
PubMed 10890950Howard 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.
PubMed 10096613Howard 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.
PubMed 8826586Tebbetts 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.
PubMed 17099485Tebbetts 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.
PubMed 17099484Tofield JJ. Dual plane breast augmentation. Plast Reconstr Surg. 2001 Dec;108(7):2162-4. doi: 10.1097/00006534-200112000-00069. No abstract available.
PubMed 11743433Tebbetts 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.
PubMed 11373572
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Plane Breast Augmentation: Axillary Approach With Assistant of Endoscope
- ClinicalTrials.gov ID
- NCT00505557
- Acronym / sponsor ID
- 621125-1
- Conditions
- Mammoplasty
- Keywords
- augmentation mammoplasty, Dual plane, Endoscope, Transaxillary incision
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chinese Academy of SciencesOther government
- Study start
- May 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 23 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- With thin soft tissues (< 9 mm) in the low pole of the breast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transaxillary dual plane technique | Procedure or surgery | – |
Primary outcome
98% of the patient satisfied with softer, more natural breasts. The procedure provided more accurate bleeding control, faster postoperative coverage.
Time frame: within half year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2009.
- Background: PubMed 16733771Yu 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.
- Background: PubMed 10890950Villafane 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.
- Background: PubMed 10096613Howard 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.
- Background: PubMed 8826586Howard 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.
- Background: PubMed 17099485Tebbetts 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.
- Background: PubMed 17099484Tebbetts 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.
- Background: PubMed 11743433Tofield JJ. Dual plane breast augmentation. Plast Reconstr Surg. 2001 Dec;108(7):2162-4. doi: 10.1097/00006534-200112000-00069. No abstract available.
- Background: PubMed 11373572Tebbetts 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yilin Cao, M.D. study chair
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transaxillary dual plane technique in people with Mammoplasty, run by Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
98% of the patient satisfied with softer, more natural breasts. The procedure provided more accurate bleeding control, faster postoperative coverage. (time frame: within half year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00505557, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2009.