White Light Scanning to Aid Body Contouring: A Pilot Project

A white light scanner can more accurately measure body contouring subjects than standard anthropomorphic methods.

Study Overview

• Status: Unknown
• Conditions: Lipodystrophy; Body Dysmorphic Disorders

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: David A Gilbert, MD; Phone Number: 757-274-4000; Email: dagilb3@msn.com
• Study Contact Backup: Name: ROBERT H SCHNARRS, MD; Phone Number: 757-274-4000; Email: HAGUE400@AOL.COM

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • Recruiting
      • The Hague Center
      • Contact: David A Gilbert, MD; Phone Number: 757-274-4000; Email: dagilb3@msn.com
      • Principal Investigator: David A. Gilbert, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• All healthy preoperative body contouring subjects between 18-65 years old are potentially included in this study.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eastern Virginia Medical School
• Collaborators: Novaptus Systems Incorporated
• Investigators: Principal Investigator: David A Gilbert, MD, Eastern Virginia Medical School

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: March 9, 2010
• First Submitted That Met QC Criteria: March 25, 2010
• First Posted (Estimate): March 26, 2010

Study Record Updates

• Last Update Posted (Estimate): October 9, 2014
• Last Update Submitted That Met QC Criteria: October 7, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: anthropometric; white light scanner; extraction profiles; Body lipodystrophy
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Skin Diseases; Lipid Metabolism Disorders; Somatoform Disorders; Skin Diseases, Metabolic; Lipodystrophy; Body Dysmorphic Disorders
• Other Study ID Numbers: 05-09-FB-0235