Diagnostic Ultrasound for Measuring Fat of the Body

• Sponsor: Northwestern University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03871556
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 44.4
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Subcutaneous Fat	Diagnostic Test: LOGIQ P6 Diagnostic Ultrasound	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Diagnostic Ultrasound for Measuring Fat of the Body
• Actual Study Start Date: Mar 20, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Difference in thickness of subcutaneous fat at different anatomic sites on the body [through study completion, 1 day]

   Will use diagnostic ultrasound to measure fat thickness

2. Correlation of patient perceptions of body image with measured fat distribution [through study completion, 1 day]

   Will use diagnostic ultrasound to measure fat thickness and a questionnaire to assess subject perceptions of their body

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Murad Alam, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT03871556
• Other Study ID Numbers: STU002089391
• First Posted: Mar 12, 2019
• Last Update Posted: Jan 5, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Jan 5, 2022