White Light Scanning to Aid Body Contouring: A Pilot Project

Lipodystrophy Clinical Trial

Official title:

White Light Scanning to Aid Body Contouring: A Pilot Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01093950
• Other study ID #: 05-09-FB-0235
• Status: Recruiting
• Phase: N/A
• First received: March 9, 2010
• Last updated: October 7, 2014
• Start date: January 2005
• Est. completion date: October 2020

Study information

• Verified date: October 2014
• Source: Eastern Virginia Medical School
• Contact: DAVID A GILBERT, MD
• Phone: 757-274-4000
• Email: Dagilb3[@]msn.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Dysmorphic Disorders
• Lipodystrophy

Locations

Country	Name	City	State
United States	The Hague Center	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Virginia Medical School	Novaptus Systems Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No