White Light Scanning to Aid Body Contouring: A Pilot Project
1 other identifier
observational
500
1 country
1
Brief Summary
A white light scanner can more accurately measure body contouring subjects than standard anthropomorphic methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 9, 2010
CompletedFirst Posted
Study publicly available on registry
March 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedOctober 9, 2014
October 1, 2014
15.6 years
March 9, 2010
October 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
9 months
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- All healthy preoperative body contouring subjects between 18-65 years old are potentially included in this study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eastern Virginia Medical Schoollead
- Novaptus Systems Incorporatedcollaborator
Study Sites (1)
The Hague Center
Norfolk, Virginia, 23510, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David A Gilbert, MD
Eastern Virginia Medical School
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 9, 2010
First Posted
March 26, 2010
Study Start
January 1, 2005
Primary Completion
August 1, 2020
Study Completion
October 1, 2020
Last Updated
October 9, 2014
Record last verified: 2014-10