LipodystrophyNCT01093950
White Light Scanning to Aid Body Contouring: A Pilot Project
An observational study of Lipodystrophy and Body Dysmorphic Disorders, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
A white light scanner can more accurately measure body contouring subjects than standard anthropomorphic methods. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipodystrophy, Body Dysmorphic Disorders
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Oct 2020
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy, prospective, surgical candidates for body contouring surgery, including: lipoplasty, abdominoplasty, breast reduction, breast augmentation, thigh lift,and brachioplasty are being asked to participate in this research project.
Who may be able to join
- All healthy preoperative body contouring subjects between 18-65 years old are potentially included in this study.
Who cannot join
- Pregnant, nursing,or have a history of epilepsy.
- Individuals under 18 years old;
- Problems reading or understanding spoken instructions;
- Are in jail or in a "locked ward";
- Are a student or an employee of EVMS; or
- Are chemically-dependent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Hague Center
Norfolk, Virginia, 23510
David A Gilbert, MD, 757-274-4000, dagilb3@msn.com
David A. Gilbert, MD
About this study
A white light scanner can more accurately measure body contouring subjects than standard anthropomorphic methods.
Read the detailed description
A 3-D digital body camera that employs non-intrusive white light phase profilometry and 24 coordinated charge-coupled cameras scans and produces a "point cloud" image of the subject. The result of the two-minute scan process is an accurate three-dimensional body model of the subject, consisting of over 1.2 million surface points. The point cloud is compressed to provide programmable measurement extraction profiles (MEP's) that automatically extracts linear and circumferential measurements. Subjects are scanned and anthropometrically measured pre-operatively, and at 3, 6 and 9 months post-op.
- Conditions
- Lipodystrophy, Body Dysmorphic Disorders
- Keywords
- anthropometric, white light scanner, extraction profiles, Body lipodystrophy
- Medical subject headings
- Lipodystrophy, Body Dysmorphic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PROSPECTIVE BODY CONTOURING SUBJECTS | It is anticipated that the participants will undergo body contouring procedures including lipoplasty [internal fat suction removal], abdominoplasty [surgical removal of lower abdominal skin and fat], breast reduction [surgical removal of breast skin, fat, and breast tissue to reduce breast size], breast augmentation [surgical breast enlargement], thigh lift [surgical removal of upper thigh tissue], and brachioplasty [surgical removal of upper arm tissue]. These procedures will be evaluated by pre- and post-operative digital scans, analog measurements, and clinical examinations and photographs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study whether the scanner was faster and more accurate than anthropometric measurements.
The scanner and anthropometric measurements will be compared for accuracy and fidelity of collection. Anthropometric tape measurements will be compared to measurement extraction profiles provided by the scanner.Conclusions will be drawn based on the data collected.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startJan 2005
- Primary completionAug 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipodystrophyStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Novaptus Systems Incorporated
- Responsible party
- Principal investigator, David Gilbert, Eastern Virginia Medical School
- Investigators
- David A Gilbert, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093950
- Sponsor's protocol ID
- 05-09-FB-0235
- Status last verified
- Oct 2014
- First submitted
- 9 Mar 2010
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Light Scanning to Aid Body Contouring: A Pilot Project
- ClinicalTrials.gov ID
- NCT01093950
- Acronym / sponsor ID
- 05-09-FB-0235
- Conditions
- Lipodystrophy, Body Dysmorphic Disorders
- Keywords
- anthropometric, white light scanner, extraction profiles, Body lipodystrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- Novaptus Systems Incorporated
- Study start
- Jan 2005
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 26 Mar 2010 (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 white light scanner can more accurately measure body contouring subjects than standard anthropomorphic methods.
Detailed description
A 3-D digital body camera that employs non-intrusive white light phase profilometry and 24 coordinated charge-coupled cameras scans and produces a "point cloud" image of the subject. The result of the two-minute scan process is an accurate three-dimensional body model of the subject, consisting of over 1.2 million surface points. The point cloud is compressed to provide programmable measurement extraction profiles (MEP's) that automatically extracts linear and circumferential measurements. Subjects are scanned and anthropometrically measured pre-operatively, and at 3, 6 and 9 months post-op.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROSPECTIVE BODY CONTOURING SUBJECTS | – | –It is anticipated that the participants will undergo body contouring procedures including lipoplasty [internal fat suction removal], abdominoplasty [surgical removal of lower abdominal skin and fat], breast reduction [surgical removal of breast skin, fat, and breast tissue to reduce breast size], breast augmentation [surgical breast enlargement], thigh lift [surgical removal of upper thigh tissue], and brachioplasty [surgical removal of upper arm tissue]. These procedures will be evaluated by pre- and post-operative digital scans, analog measurements, and clinical examinations and photographs. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy, prospective, surgical candidates for body contouring surgery, including: lipoplasty, abdominoplasty, breast reduction, breast augmentation, thigh lift,and brachioplasty are being asked to participate in this research project.
Key inclusion criteria (1 listed)
- All healthy preoperative body contouring subjects between 18-65 years old are potentially included in this study.
Key exclusion criteria (6 listed)
- Pregnant, nursing,or have a history of epilepsy.
- Individuals under 18 years old;
- Problems reading or understanding spoken instructions;
- Are in jail or in a "locked ward";
- Are a student or an employee of EVMS; or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To study whether the scanner was faster and more accurate than anthropometric measurements.
Time frame: 9 months
The scanner and anthropometric measurements will be compared for accuracy and fidelity of collection. Anthropometric tape measurements will be compared to measurement extraction profiles provided by the scanner.Conclusions will be drawn based on the data collected.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
Related trials for Lipodystrophy
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Metabolic Phenotyping in vEDS
Vascular Ehlers-Danlos Syndrome, Vascular Ehlers Danlos Syndrome
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
Active, not recruitingPhase 2
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Diabetes, Lipodystrophy
RecruitingPhase 3
Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
Generalized Lipodystrophy
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.
David A Gilbert, MD principal investigator
Eastern Virginia Medical School
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 Lipodystrophy and Body Dysmorphic Disorders, run by Eastern Virginia Medical School 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 1 inclusion and 6 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 9 Oct 2014. 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 DAVID A GILBERT, MD (757-274-4000, Dagilb3@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study whether the scanner was faster and more accurate than anthropometric measurements. (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 9 Oct 2014.