NCT01093950

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

15.6 years

First QC Date

March 9, 2010

Last Update Submit

October 7, 2014

Conditions

Keywords

anthropometricwhite light scannerextraction profilesBody lipodystrophy

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

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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

Study Sites (1)

The Hague Center

Norfolk, Virginia, 23510, United States

RECRUITING

MeSH Terms

Conditions

LipodystrophyBody Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Skin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSomatoform DisordersMental Disorders

Study Officials

  • David A Gilbert, MD

    Eastern Virginia Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DAVID A GILBERT, MD

CONTACT

ROBERT H SCHNARRS, MD

CONTACT

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

Locations