Diagnostic Ultrasound for Measuring Fat of the Body

The purpose of this study is to provide information about human subcutaneous fat thickness at different anatomic sites on the body by measuring these thicknesses with a diagnostic ultrasound and also by correlating patient perceptions of body image with measured fat distribution.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

Study Overview

• Status: Completed
• Conditions: Subcutaneous Fat
• Intervention / Treatment: Diagnostic test: LOGIQ P6 Diagnostic Ultrasound

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males or females 18-85 years old.
• Subjects are in good health as judged by the investigator.
• Subjects with Body Mass Index (BMI) between 18-29.99.
• Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator

Exclusion Criteria:

• Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments
• Pregnant or breast feeding
• Uncooperative patients or patients with neurological disorders who are incapable of following directions
• Subjects who are unable to understand the protocol or give informed consent (including non-English speaking patients)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group	Diagnostic test: LOGIQ P6 Diagnostic Ultrasound; Ultrasound measurements of subcutaneous fat thickness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Thickness of Subcutaneous Fat at Different Anatomic Sites on the Body	Will use diagnostic ultrasound to measure fat thickness	through study completion, 1 day
Gender Differences on Patient Perceptions of Body Image With Measured Fat Distribution	Will use diagnostic ultrasound to measure fat thickness and a questionnaire to assess subject perceptions of their body using a 10-point Likert scale (1= very unsatisfied, 10= very satisfied)	through study completion, 1 day

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Murad Alam, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): October 2, 2022
• Study Completion (Actual): October 2, 2022

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STU002089391

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes