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White Light Scanning to Aid Body Contouring: A Pilot Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Eastern Virginia Medical School
Sponsor:
Collaborator:
Novaptus Systems, Inc.
Information provided by (Responsible Party):
David Gilbert, Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT01093950
First received: March 9, 2010
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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


Condition
Lipodystrophy
Body Dysmorphic Disorders

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: White Light Scanning to Aid Body Contouring: A Pilot Project

Resource links provided by NLM:


Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:
  • To study whether the scanner was faster and more accurate than anthropometric measurements. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: January 2005
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093950

Contacts
Contact: DAVID A GILBERT, MD 757-274-4000 Dagilb3@msn.com
Contact: ROBERT H SCHNARRS, MD 757-274-4000 HAGUE400@AOL.COM

Locations
United States, Virginia
The Hague Center Recruiting
Norfolk, Virginia, United States, 23510
Contact: David A Gilbert, MD    757-274-4000    dagilb3@msn.com   
Principal Investigator: David A. Gilbert, MD         
Sponsors and Collaborators
Eastern Virginia Medical School
Novaptus Systems, Inc.
Investigators
Principal Investigator: David A Gilbert, MD Eastern Virginia Medical School
  More Information

No publications provided

Responsible Party: David Gilbert, Principal Investigator, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01093950     History of Changes
Other Study ID Numbers: 05-09-FB-0235
Study First Received: March 9, 2010
Last Updated: October 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Eastern Virginia Medical School:
anthropometric
white light scanner
extraction profiles
Body lipodystrophy

Additional relevant MeSH terms:
Body Dysmorphic Disorders
Lipodystrophy
Lipid Metabolism Disorders
Mental Disorders
Metabolic Diseases
Skin Diseases
Skin Diseases, Metabolic
Somatoform Disorders

ClinicalTrials.gov processed this record on November 24, 2014