Autologous Fat GraftingNCT03544593
The Volumetric Analysis of Fat Grafting
A study testing Revolve System in people with Autologous Fat Grafting, run by Hunstad Kortesis Bharti Cosmetic Sugrery at 1 site in United States.
Trial summary
Title: The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring. Subjects who wish to undergo fat grafting for aesthetic body contouring will be offered enrollment to the study. The study will consist of a Screening/Baseline visit, Surgery day and 3 follow up visits. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Autologous Fat Grafting
- What is being tested?
- Revolve System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2018to Mar 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females or Males in good general health age 18 - 65 years of age
- Must be willing to give and sign a HIPAA form and informed consent form
- Must be willing and able to comply with all study protocols and schedules
- Negative urine pregnancy test prior to surgery treatment (if applicable)
- The patient must have had a stable weight (no fluctuation of >15 pounds in a year), diet, and physical activity for the previous 6 months
Who cannot join
- Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial
- History of breast cancer if fat grafting to breasts
- Patients who smoke or use nicotine products
- Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- Diabetes Mellitus
- Subject has a clinically significant coagulation disorder or disease, defined as a platelet count < 100,000 per microliter or International Normalized Ratio > 1.5 within 4 weeks of surgery
Show all 10Show fewer
- Patients under the age of 18
- Patients undergoing fat grafting but refuse enrollment
- Patients with an active infection
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kelly Costin
Huntersville, North Carolina, 28078
Kelly Costin, RN, BSN, 704-659-9000, kelly.c@hkbsurgery.com
Bill G Kortesis, MD
About this study
Official title: The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring
Title: The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring.
Subjects who wish to undergo fat grafting for aesthetic body contouring will be offered enrollment to the study. The study will consist of a Screening/Baseline visit, Surgery day and 3 follow up visits. Each follow up visit will utilize Vectra 3D photography (Canfeild, NJ) to collect volumetric data. At the conclusion of the study, Volume data from Baseline and 3 follow up visits will be analyzed to determine fat retention rates.
- Conditions
- Autologous Fat Grafting
- Being tested
- Revolve System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revolve SystemDevice
Fat grafting system
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft retention
Vectra 3D volumetric analysis will be utilized to evaluate graft retention.
Measured: 9 months
Secondary outcomes (4)
Volume of adipose harvested (mL)
Measured: Intra Op
Volume of adipocyte injected (mL)
Measured: Intra Op
Operating room time (harvesting, processing, and reinjection time) (min)
Measured: Intra Op
Standardized before and after photos
Measured: Pre op, 3 months, 6 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start4 Jan 2018
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Fat GraftingStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunstad Kortesis Bharti Cosmetic Sugrery
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Bill G Kortesis, MD, Hunstad Kortesis Bharti Cosmetic Sugrery
- Investigators
- Kelly Costin, RN, BSN, Study director, Hunstad Kortesis Bharti Cosmetic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544593
- Sponsor's protocol ID
- 11-01-2017
- Status last verified
- May 2018
- First submitted
- 8 May 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring
- ClinicalTrials.gov ID
- NCT03544593
- Acronym / sponsor ID
- 11-01-2017
- Conditions
- Autologous Fat Grafting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hunstad Kortesis Bharti Cosmetic SugreryUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 4 Jun 2018 (actual)
- 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.
Title: The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring.
Subjects who wish to undergo fat grafting for aesthetic body contouring will be offered enrollment to the study. The study will consist of a Screening/Baseline visit, Surgery day and 3 follow up visits. Each follow up visit will utilize Vectra 3D photography (Canfeild, NJ) to collect volumetric data. At the conclusion of the study, Volume data from Baseline and 3 follow up visits will be analyzed to determine fat retention rates.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females or Males in good general health age 18 - 65 years of age
- Must be willing to give and sign a HIPAA form and informed consent form
- Must be willing and able to comply with all study protocols and schedules
- Negative urine pregnancy test prior to surgery treatment (if applicable)
- The patient must have had a stable weight (no fluctuation of >15 pounds in a year), diet, and physical activity for the previous 6 months
Key exclusion criteria (10 listed)
- Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial
- History of breast cancer if fat grafting to breasts
- Patients who smoke or use nicotine products
- Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- Diabetes Mellitus
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 |
|---|---|---|
| Revolve SystemFat grafting system | Device | – |
Primary outcome
Graft retention
Time frame: 9 months
Vectra 3D volumetric analysis will be utilized to evaluate graft retention.
4 secondary outcomes
Volume of adipose harvested (mL)
Time frame: Intra Op
Volume of adipocyte injected (mL)
Time frame: Intra Op
Operating room time (harvesting, processing, and reinjection time) (min)
Time frame: Intra Op
Standardized before and after photos
Time frame: Pre op, 3 months, 6 months, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
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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.
Kelly Costin, RN, BSN study director
Hunstad Kortesis Bharti Cosmetic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revolve System in people with Autologous Fat Grafting, run by Hunstad Kortesis Bharti Cosmetic Sugrery 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 4 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Costin, RN, BSN (7046599000, kelly.c@hkbsurgery.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft retention (time frame: 9 months). 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 4 Jun 2018.