Cosmetic and Circumferential Change After Fat TransferNCT01313000
Study To Evaluate Upper Arm Autologous Fat Transfer
An observational study of Cosmetic and Circumferential Change After Fat Transfer, run by Sound Surgical Technologies, LLC. at 1 site in United States.
Trial summary
The objective of this pilot study is to observe the utility of autologous transfer of fat collected using ultrasonic assisted liposuction into the upper arms with ultrasonic visualization. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cosmetic and Circumferential Change After Fat Transfer
- What is being tested?
- Autologous fat transfer
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2012
- Phase
- Observational
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Male patients undergoing abdominal liposuction who wish autologous fat transfer to the upper arms
Who may be able to join
- Is male.
- Is between 20 and 50 years of age, inclusive, on the day of enrolment.
- Is to undergo abdominal liposuction.
- Wishes to undergo autologous fat transfer to the upper arms.
Who cannot join
- Currently enrolled in another device or drug study that has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days before enrolment in this study.
- Undergoing body contouring for reconstruction following injury or disease.
- Deemed inappropriate candidates for the surgical procedures for any reason.
- Are unwilling to undergo the study procedures or participate fully in all follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study To Evaluate Upper Arm Autologous Fat Transfer
The objective of this pilot study is to observe the utility of autologous transfer of fat collected using ultrasonic assisted liposuction into the upper arms with ultrasonic visualization.
- Being tested
- Autologous fat transfer
- Keywords
- fat, transfer, autologous fat transfer, bicep
- Medical subject headings
- Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous fat transferProcedure or surgery
Autologous fat transfer from abdomen to upper arms
| Study group | Role | What they receive |
|---|---|---|
| Autologous fat transfer | Not described Receives: Procedure: Autologous fat transfer |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cosmetic and Circumferential Change After Fat TransferStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sound Surgical Technologies, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313000
- Sponsor's protocol ID
- SST2001-1
- Status last verified
- Mar 2012
- First submitted
- 9 Mar 2011
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study To Evaluate Upper Arm Autologous Fat Transfer
- ClinicalTrials.gov ID
- NCT01313000
- Acronym / sponsor ID
- SST2001-1
- Keywords
- fat, transfer, autologous fat transfer, bicep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sound Surgical Technologies, LLC.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Mar 2011 (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 objective of this pilot study is to observe the utility of autologous transfer of fat collected using ultrasonic assisted liposuction into the upper arms with ultrasonic visualization.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous fat transfer | – | Procedure: Autologous fat transfer |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male patients undergoing abdominal liposuction who wish autologous fat transfer to the upper arms
Key inclusion criteria (4 listed)
- Is male.
- Is between 20 and 50 years of age, inclusive, on the day of enrolment.
- Is to undergo abdominal liposuction.
- Wishes to undergo autologous fat transfer to the upper arms.
Key exclusion criteria (4 listed)
- Currently enrolled in another device or drug study that has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days before enrolment in this study.
- Undergoing body contouring for reconstruction following injury or disease.
- Deemed inappropriate candidates for the surgical procedures for any reason.
- Are unwilling to undergo the study procedures or participate fully in all follow-up.
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 transferAutologous fat transfer from abdomen to upper arms | Procedure or surgery | Autologous fat transfer |
Primary outcome
Not reported in the source record.
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 26 Mar 2012.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cosmetic and Circumferential Change After Fat Transfer, run by Sound Surgical Technologies, LLC. at 1 site in United States.
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 4 inclusion and 4 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 26 Mar 2012. 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 United States. 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.
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.
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 26 Mar 2012.