Breast ImplantationNCT02551939
Breast Fat Grafting Augmentation in Chinese Women
A study testing Autologous Fat Grafting in people with Breast Implantation, run by Nanjing Medical University.
Trial summary
A total of 38 Chinese healthy women underwent autologous fat grafting for cosmetic breast augmentation. Breast volumes were measured by magnetic resonance imaging preoperatively and 1 year after the procedure. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Implantation
- What is being tested?
- Autologous Fat Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jan 2014
- Phase
- Interventional
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women agreed to participate in the study
Who cannot join
- Patients who had breast surgery previously
- Women on the lactation or gestation period
About this study
Official title: Magnetic Resonance Imaging and Breast-Q Evaluation After Breast Autologous Fat Grafting Augmentation in Chinese Women
A total of 38 Chinese healthy women underwent autologous fat grafting for cosmetic breast augmentation. Breast volumes were measured by magnetic resonance imaging preoperatively and 1 year after the procedure. Furthermore, BREAST-Q was used to analyze the satisfaction and well-being of patients during the preoperative and 1 year post operation.
Read the detailed description
Autologous fat was obtained from thighs, waist or abdomen using resonance liposuction instrument. Fat was injected into the tissues in a multitunnel and multilayer way until they were firm and appeared fully tumesced according to the Coleman method.All MRI volume analyses were blindly performed by examiner independently preoperatively and 1 year postoperatively. Object marking was done using avanto 1.5T superconducting magnetic resonance scanner.Volume analysis was done by counting pixels within the frames of the MRI using ImageChecker CAD software.The Chinese version of BREAST-Q augmentation module was obtained from the Memorial Sloan-Kettering Cancer Center and the University of British Columbia. 38 patients were given the BREAST-Q questionnaire to express their thoughts preoperatively and 1 year postoperatively. Data were calculated using the Q-score program, which converts raw BREAST-Q scores of 1 through 4 or 5 to scores of 0 to 100.
- Conditions
- Breast Implantation
- Being tested
- Autologous Fat Grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fat GraftingProcedure or surgery
Autologous Fat Grafting
| Study group | Role | What they receive |
|---|---|---|
| fat graft | Experimental | Autologous Fat Grafting Receives: Procedure: Autologous Fat Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast volumes were measured by magnetic resonance imaging
Measured: one year
BREAST-Questionaire was used to analyze the satisfaction and well-being of patients
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ImplantationStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Li, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551939
- Sponsor's protocol ID
- 201352
- Status last verified
- Sep 2015
- First submitted
- 13 Sep 2015
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging and Breast-Q Evaluation After Breast Autologous Fat Grafting Augmentation in Chinese Women
- ClinicalTrials.gov ID
- NCT02551939
- Acronym / sponsor ID
- 201352
- Conditions
- Breast Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Sep 2015 (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.
A total of 38 Chinese healthy women underwent autologous fat grafting for cosmetic breast augmentation. Breast volumes were measured by magnetic resonance imaging preoperatively and 1 year after the procedure. Furthermore, BREAST-Q was used to analyze the satisfaction and well-being of patients during the preoperative and 1 year post operation.
Detailed description
Autologous fat was obtained from thighs, waist or abdomen using resonance liposuction instrument. Fat was injected into the tissues in a multitunnel and multilayer way until they were firm and appeared fully tumesced according to the Coleman method.All MRI volume analyses were blindly performed by examiner independently preoperatively and 1 year postoperatively. Object marking was done using avanto 1.5T superconducting magnetic resonance scanner.Volume analysis was done by counting pixels within the frames of the MRI using ImageChecker CAD software.The Chinese version of BREAST-Q augmentation module was obtained from the Memorial Sloan-Kettering Cancer Center and the University of British Columbia. 38 patients were given the BREAST-Q questionnaire to express their thoughts preoperatively and 1 year postoperatively. Data were calculated using the Q-score program, which converts raw BREAST-Q scores of 1 through 4 or 5 to scores of 0 to 100.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fat graft | Experimental | Procedure: Autologous Fat GraftingAutologous Fat Grafting |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy women agreed to participate in the study
Key exclusion criteria (2 listed)
- Patients who had breast surgery previously
- Women on the lactation or gestation period
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 |
|---|---|---|
| Autologous Fat GraftingAutologous Fat Grafting | Procedure or surgery | fat graft |
Primary outcome
Breast volumes were measured by magnetic resonance imaging
Time frame: one year
BREAST-Questionaire was used to analyze the satisfaction and well-being of patients
Time frame: one year
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 16 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Fat Grafting in people with Breast Implantation, run by Nanjing Medical University.
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 1 inclusion and 2 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 16 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Breast volumes were measured by magnetic resonance imaging (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2015.