White Light Scanning to Aid Body Contouring: A Pilot Project

NCT ID: NCT01093950

Last Updated: 2014-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2020-10-31

Brief Summary

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

Detailed Description

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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

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Lipodystrophy Body Dysmorphic Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novaptus Systems Incorporated

INDUSTRY

Sponsor Role collaborator

Eastern Virginia Medical School

OTHER

Sponsor Role lead

Responsible Party

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David Gilbert

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David A Gilbert, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School

Locations

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The Hague Center

Norfolk, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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DAVID A GILBERT, MD

Role: CONTACT

757-274-4000

ROBERT H SCHNARRS, MD

Role: CONTACT

757-274-4000

Facility Contacts

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David A Gilbert, MD

Role: primary

757-274-4000

Other Identifiers

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05-09-FB-0235

Identifier Type: -

Identifier Source: org_study_id

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